Institute of Medicine vitamin D recommendation challenged


The National Academy of Sciences Institute of Medicine miscalculated the recommended dietary allowance for vitamin D by an order of magnitude, according to two groups of researchers.

Although the level of a nutrient needed to meet the health requirements of almost all healthy individuals is an estimate, a more accurate intake would be about 10 times the Institute of Medicine (IOM) recommendation of 600 IU per day for individuals aged 1 to 70 years, according to a letters published in the journal Nutrients.

Using the same data analyzed by the IOM, Paul J. Veuglers, PhD, and John Paul Ekwaru, PhD, of the University of Alberta School of Public Health in Canada, calculated a dietary requirement of 8,895 IU of vitamin D per day.

Robert Heaney, MD, of Creighton University in Omaha, Nebraska, and colleagues at other institutions examined data from the GrassrootsHealth database; their analysis yielded an estimate near 7,000 IU vitamin D per day — much closer to Veuglers’ and Ekwaru’s estimate than that of the IOM.

“Thus we confirm the findings of [Veuglers and Ekwaru] with regard to the published [recommended dietary allowance (RDA)] for vitamin D, and we call for the IOM and all public health authorities concerned with transmitting accurate nutritional information to the public to designate, as the RDA a value of approximately 7,000 IU per day from all sources,” Heaney and colleagues wrote. – by Jill Rollet

Report Finds ‘Culture of Resistance’ on Youth Concussion.


Young athletes in the United States face a “culture of resistance” to telling a coach or parent they might have a concussion, according to a new report from the Institute of Medicine and National Research Council. 

The 306-page report, “Sports-Related Concussions in Youth: Improving the Science, Changing the Culture,” was released during a briefing today at the National Academy of Sciences in Washington, DC.

“Even though there is an increased willingness to report a concussion, there is still the desire on the part of the athlete not to report it because they feel they are letting their teammates down; on the part of the coaches because it upsets the team they have on the field, or their own belief that, ‘I had these, I’m okay, it’s just part of the sport’; and on the part of the parents who want to see their children excel and be accepted,” said Robert Graham, MD, chair of the committee that wrote the report.

Attitude Adjustment

Efforts are needed to “change the culture,” said Dr. Graham, who is director of the National Program Office for Aligning Forces for Quality at George Washington University in Washington, DC.

Over 9 months, the committee did a comprehensive review of the literature on concussions in youth sports with athletes aged 5 to 21 years. 

“The findings of our report justify the concerns about sports concussions in young people,” said Dr. Graham. “However, there are numerous areas in which we need more and better data.  Until we have that information, we urge parents, schools, athletic departments, and the public to examine carefully what we do know, as with any decision regarding risk, so they can make more informed decisions about young athletes playing sports,” he added.

The reported number of individuals aged 19 and under treated in US emergency departments for concussions and other nonfatal sports- and recreation-related traumatic brain injuries (TBIs) increased from 150,000 in 2001 to 250,000 in 2009.

“This could possibly be due to an increase in awareness or reporting of concussions,” committee member Tracey Covassin, PhD, director of the undergraduate athletic training program at Michigan State University in East Lansing. “However, we do not know the true incidence of concussions as several concussions go unreported, as well as a lack of consistency in terminology with different studies that have reported different definitions of concussions.”

The committee found that the majority of research into concussions is at the high school and collegiate levels, with very few to no data reported below the high school level.

The committee also found a “shift” in the incidence of concussions, with more reported at the high school level than the collegiate level, Dr. Covassin said.

Football, ice hockey, lacrosse, wrestling, and soccer are associated with the highest rates of reported concussions for male athletes at the high school and college levels, while soccer, lacrosse, and basketball are associated with the highest rates of reported concussions for female athletes at these levels of play.

Limited Evidence Helmets Cut Risk

The committee found little evidence that current sports helmet designs cut the risk for concussions. 

“What the literature tells us is that diffuse brain injuries like concussion are caused by a combination of linear and rotational forces,” explained committee member Kristy Arbogast, PhD, engineering core director, Center for Injury Research and Prevention, Children’s Hospital of Philadelphia in Pennsylvania. “What we do know is that helmets reduce that linear portion. There is limited evidence that they can manage the rotational components of the impact. This is in part due to standards.”

The committee stressed, however, that properly fitted helmets, face masks, and mouth guards should still be used because they reduce the risk for other injuries.

The committee also examined the scientific literature on concussion recognition, diagnosis, and management. They found that the signs and symptoms of concussion are usually placed into 4 categories — physical, cognitive, emotional, and sleep — with patients having 1 or more symptoms from 1 or more categories. 

Most youth athletes with concussion will recover within 2 weeks of the injury, but in 10% to 20% of cases concussion symptoms persist for several weeks, months, or even years. 

Return to Play

The committee advises that a concussed athlete return to play only when he or she has recovered demonstrably and is no longer having any symptoms. An individualized treatment plan that includes physical and mental rest may be beneficial for recovery from a concussion, but current research does not suggest a standard or universal level and duration of rest needed, the committee notes.

Athletes who return to play before complete recovery are at increased risk for prolonged recovery or more serious consequences if they sustain a second concussion. “The evidence is pretty clear” on this, said committee member Arthur Maerlender, PhD, director of pediatric neuropsychological services at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire.

The literature also suggests that single and multiple concussions can lead to impairments in the areas of memory and processing speed.  However, it remains unclear whether repetitive head impacts and multiple concussions sustained in youth lead to long-term neurodegenerative disease, such as chronic traumatic encephalopathy, the committee said.

It notes, however, that surveys of retired professional athletes provide some evidence that a history of multiple concussions increases risk for depression. In a survey of more than 2500 retired professional football players, approximately 11% reported having clinical depression. “Very little” research has evaluated the relationship between concussions and suicidal thoughts and behaviors, the committee notes.

In youth sports, several organizations have called for a “hit count” to limit the amount of head contact a player receives over a given amount of time. Although this concept is “fundamentally sound,” the committee found that implementing a specific threshold for the number of impacts or the magnitude of impacts per week or per season is without scientific basis.

The committee calls for establishing a national surveillance system to accurately determine the number of sports-related concussions, identify changes in the brain following concussions in youth, conduct studies to assess the consequences and effects of concussions over a life span, and evaluate the effectiveness of sports rules and playing practices in reducing concussions. 

Decriminalisation of psilocybin could help millions.


Previous studies have shown that low doses of psilocybin produce no consciousness state altering effects. Administered in the correct amount, psilocybin could therefore be assumed to safely treat PTSD with minimal risk of adverse side effects. Magic mushrooms could help millions recover from the debilitating cycles of fight and flight and other conditioned biological responses caused by extreme trauma, if only they weren’t listed as a dangerous Schedule 1 drug with no medical benefits.
Meanwhile, doctors are authorised to dispense powerful, side-effect laden pharmaceutical drugs to army vets and others suffering from the symptoms of PTSD without any evidence that these treatments actually work, according to a major review by the committee of the Institute of Medicine on the topic.

The situation is so bad that an average of 18 American veterans commits suicide every day (http://www.naturalnews.com), linked to the sharp rise in prescription drugs, depression, and other psychological conditions. Safe, natural alternatives to pharmaceuticals such as homeopathic and herbal remedies have been found to alleviate symptoms (http://www.naturalnews.com). Meditation has also been shown to reduce high activity levels in the amygdala (the brain’s emotional centre) experienced in PTSD sufferers as anxiety, stress and phobias.

Sources used in this article:

http://www.ptsdalliance.org

http://intellihub.com

http://digitaljournal.com

http://www.thedoctorwillseeyounow.com

Zolpidem and Driving Impairment — Identifying Persons at Risk.


Zolpidem (Ambien, Sanofi) is the most widely used prescription drug for insomnia and one of the most commonly used drugs in the United States. Treatment of insomnia, which has important effects on patients’ quality of life, may also have larger public health benefits. In its 2006 report, the Institute of Medicine (IOM) Committee on Sleep Medicine and Research concluded that sleep deprivation and sleep disorders represent an unaddressed public health problem that has substantial health consequences and leads to high health care costs.1 The IOM noted that one of every five serious injuries from driving accidents can be attributed to driver sleepiness. Numerous sleep drugs are available for treating insomnia and are also used to reduce next-day somnolence. But it is widely recognized that these drugs themselves can sometimes contribute to next-day somnolence, depending on such factors as drug dose, dosage form, and individual patient characteristics.

The treatment of insomnia may focus on two distinct problems: falling asleep and remaining asleep; drugs that treat insomnia may be directed at one or both of these problems. For patients whose main problem is falling asleep, shorter-acting drugs can be effective without conferring a risk of sedation the following morning. When the problem is staying asleep during the night (sleep maintenance), longer-acting drugs — drugs with longer half-lives or controlled-release formulations — are generally used. Some patients can also take a very small dose of a sleep drug (e.g., zolpidem is available at a dose of 1.75 to 3.5 mg) or a very short-acting drug (e.g., zaleplon) if they wake up in the middle of the night and have difficulty falling back asleep.

Zolpidem was initially approved, in 1992, in an immediate-release formulation (Ambien) for insomnia characterized by difficulty in falling asleep. At the time of its approval, there was concern regarding morning impairment, even after a 7-to-8-hour period of sleep, particularly with regard to activities requiring full alertness, such as driving a motor vehicle. There was also some recognition that people’s risk of impairment could vary, and the drug label advised that “the dose of Ambien should be individualized.” Although the recommended adult dose was 10 mg, the recommended dose for the elderly (who had higher levels of the drug in their blood the next morning) and for patients with hepatic impairment (who metabolized the drug more slowly) was 5 mg. Individual differences became more apparent as new dosage forms of zolpidem were developed to address sleep maintenance and middle-of-the-night waking.

In 2005, a modified-release formulation of zolpidem (Ambien CR, Sanofi) was approved for insomnia characterized by difficulty falling asleep, difficulty staying asleep, or both; it came in a 12.5-mg dose. In 2011, a sublingual, lower-dose tablet (Intermezzo, Purdue) was approved for difficulty falling back to sleep after a middle-of-the-night awakening. Intermezzo was labeled so as to provide doses of zolpidem that differed for men and women (3.5 mg for men and 1.75 mg for women), since new data revealed a difference between men and women in morning blood drug levels.

The review and approval of Intermezzo was particularly informative, because a study was conducted to assess the relationship between blood zolpidem levels and driving impairment. The study assessed patients 3 hours after taking the drug (the label instructs patients to take the product at least 4 hours before morning awakening) and revealed significant impairment in driving ability in patients whose blood concentration of zolpidem was above 50 ng per milliliter. Such impairment is thought to increase the risk of a motor vehicle accident.

Recognition of a threshold blood level that would lead to concern about driving allowed assessment of other dosage forms of zolpidem in order to determine what doses would pose a risk of morning driving impairment. In some patients — particularly women, who clear zolpidem more slowly than men — blood levels the morning after taking the recommended bedtime doses could be considerably higher than 50 ng per milliliter. Reanalysis of data from studies of immediate-release zolpidem products showed that 8 hours (i.e., a typical period of sleep) after taking 10 mg of an immediate-release zolpidem product, 15% of women and 3% of men still had blood zolpidem levels of 50 ng per milliliter or higher; when a modified-release higher-dose (12.5 mg) product was taken, the percentages were much higher — 33% of women and 25% of men. These findings, consistent with the sex difference observed with the sublingual low-dose product (Intermezzo), prompted the Food and Drug Administration (FDA) earlier this year to revise the dosing recommendations for the labels of zolpidem-containing products to lower doses, particularly for women.2,3

Manufacturers of zolpidem-containing products, such as Ambien, Ambien CR, Edluar, and Zolpimist, must now make dosage recommendations that differ for women and men, to decrease the likelihood that women will have blood levels of the drug after they wake up that will impair their driving ability. Accordingly, the recommended dose of zolpidem for women has been reduced from 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for modified-release products (e.g., Ambien CR). Although labeling will also suggest that the lower doses should be considered for men, the stronger recommendation for reduced dosage in women underscores the clear sex-associated differences in zolpidem pharmacokinetics observed in studies.

The FDA has also pointed out that the risk of impairment with modified-release formulations of zolpidem (Ambien CR and generics) is greater than the risk with immediate-release formulations.2 Accordingly, the agency announced in May 2013 that patients who take modified-release formulations, either 6.25 mg or 12.5 mg, even if they then sleep for the required 8-hour period, should refrain, for the day subsequent to using the drug, from driving or engaging in any activity that requires full alertness.3 This recommendation reflects not only the higher zolpidem content in the modified-release formulation but also the ability of the modified-release design to prolong the period of drug exposure.

Although the evaluation of driving impairment caused by prescription drugs is not new, quantitative analyses of the relationships among drug dose, blood levels, and driving impairment, as illustrated in the approval of Intermezzo and the associated review of zolpidem products, are likely to be of growing interest (and perhaps debate). It is clear that performance on a driving test cannot be directly and quantitatively translated to driving risk, but similar data about effects on performance have been used to set standards for blood alcohol levels, and the tests of performance have considerable face validity. Certainly, these data are far more informative than reports of motor vehicle accidents, in which the relation to drug dose, the time between zolpidem ingestion and the accident, and the use of ethanol or other drugs is generally uncertain. The FDA has asked the makers of insomnia drugs to submit all available data addressing the risk of residual impairment after prescribed use, and the agency is currently analyzing these data.

It could be asked why the FDA did not leave the recommended doses unchanged and continue to warn patients to watch for driving impairment. A variety of new data have shown that people affected by impairment after taking zolpidem frequently do not recognize their impaired state; patient self-perception is not an adequate gauge for impairment. Among patients whose sleep needs are satisfied with the use of the lower doses, unnecessary risk can be avoided, and as the labels point out, patients whose symptoms do not respond to the lower doses can be given the higher doses. The sex-specific labeling revisions reflect an evidence-based approach to risk management and dose individualization.

Source: NEJM

 

Sodium Reduction in PopulationsInsights From the Institute of Medicine Committee.


The recent Institute of Medicine (IOM) report regarding dietary sodium1 has generated considerable interest and debate, as well as misinterpretation by advocates on both sides. Further discussion is necessary to inform the public and the health care community and to inform public health strategies for sodium reduction.

CURRENT PUBLIC HEALTH RECOMMENDATIONS REGARDING DIETARY SODIUM

Dietary sodium intake averages approximately 3400 mg/d in US adults, far in excess of the Dietary Guidelines for Americans (DGA) recommendation of less than 2300 mg/d for those older than 2 years and less than 1500 mg/d for certain high-risk subgroups, including African Americans, individuals with hypertension, diabetes, or chronic kidney disease (CKD), or those older than 50 years.2 In contrast, the 2005 IOM Panel on Dietary Reference Intakes (DRI) for Water, Potassium, Sodium, Chloride, and Sulfate3 found insufficient evidence to derive a “recommended dietary allowance” for sodium. Instead, an “adequate intake” of 1500 mg/d of dietary sodium was determined, reflecting the minimum needed to achieve a diet adequate in essential nutrients and to cover sweat losses. Additionally, the 2005 IOM panel established a “tolerable upper intake level,” using projections from available data on the effects on blood pressure, that consumption up to 2300 mg/d was unlikely to cause harm.

Based on the strength of the blood pressure data, various US (eg, American Heart Association [AHA]) and international (eg, World Health Organization [WHO]) organizations published recommendations for sodium consumption.4– 5 Although these recommendations were somewhat different from the DGA, there was general agreement that sodium consumption is excessive worldwide and should be reduced. Despite these recommendations, more than 90% of US adults consume more than 2300 mg of sodium per day, and among the high-risk subgroups more than 98% consume more than 1500 mg of sodium per day.6

A substantial body of evidence supports efforts to reduce sodium intake. This evidence links excessive dietary sodium to high blood pressure, stroke, and cardiovascular disease (CVD).1However, effects of sodium on blood pressure cannot always be disentangled from effects of total dietary modification, and effects of other electrolytes on blood pressure remain unresolved.7Concerns have been raised that a very low sodium intake may adversely affect lipids, insulin resistance, renin, and aldosterone levels and potentially may increase risk of CVD and stroke. Some studies link sodium intakes of less than 2300 mg/d to increased risk of CVD, at least in subpopulations. Thus, debate emerged about the sodium intake target that best improves health outcomes.

In response, the US Centers for Disease Control and Prevention commissioned the IOM to convene an expert committee to examine the designs, methods, and conclusions of literature published since the 2005 DRI report.3 Specifically, the committee was asked to review and assess potential benefits and adverse outcomes of reducing sodium intake in the population, particularly in the range of 1500 to 2300 mg/d, with emphasis on the high-risk subgroups. The committee was asked to focus on studies of direct health outcomes (vs surrogate end points such as blood pressure), to comment on implications for population-based strategies to reduce sodium intake, and to identify methodologic gaps and ways to address them. The committee’s full report is published elsewhere.1

SODIUM AND DIRECT HEALTH OUTCOMES

The committee searched literature published through 2012 for relevant publications. Information also was gathered from an open public workshop. Although not its primary emphasis, the committee summarized studies published since 2003 evaluating intermediate markers, particularly blood pressure. Focusing on CVD outcomes, the committee’s assessment of evidence was guided by factors such as study design, quantitative measures of dietary sodium intake, confounder adjustment, and number and consistency of available studies.

FINDINGS AND CONCLUSIONS

General US Population. Studies linking dietary sodium intake with direct health outcomes were highly variable in methodological quality; limitations included overreporting or underreporting of sodium intake. However, when considered collectively, the evidence on direct health outcomes indicates a positive relationship between higher levels of sodium intake and risk of CVD, consistent with the known effects of sodium intake on blood pressure. Furthermore, in some studies, the association between sodium and CVD outcomes persisted after adjusting for blood pressure, suggesting that associations between sodium and CVD may be mediated through other factors (eg, effects of other electrolytes) or through pathways other than blood pressure.

Studies evaluating sodium intake in the range of 1500 to 2300 mg/d demonstrate evidence of blood pressure lowering, but no studies have examined sodium intake in that range in the general population and direct CVD outcomes. The committee found that studies on direct health outcomes were of inconsistent quality and insufficient quantity to conclude whether sodium intake of less than 2300 mg/d was associated with either a greater or lesser risk of CVD.

Population Subgroups. The committee reviewed multiple randomized trials conducted by a single team that indicated low sodium intake (up to 1840 mg/d) may lead to greater risk of adverse events in patients with heart failure (HF) with reduced ejection fraction who received aggressive therapeutic regimens. Because these therapeutic regimens were different from standard US practice, trials using regimens that more closely resemble standard US clinical practice are needed. Of note, due to allegations of duplicate publication in 2 of these trials, a meta-analysis including them was recently retracted, after the IOM report’s completion.8 Another recently published small randomized trial involving patients with acute decompensated HF showed no benefit on weight or clinical stability from a combination of sodium and fluid restriction.9

The committee reviewed 2 related studies in individuals with prehypertension that suggested benefit from lowering sodium intake to 2300 mg/d and perhaps lower, although these studies were based on small numbers of persons with sodium intake in the less than 2300 mg/d range. In contrast, for patients with diabetes, CKD, or preexisting CVD, the committee found no evidence of benefit and some evidence suggesting risk of adverse health outcomes at sodium intake of 1500 to 2300 mg/d. In studies that explored statistical interactions, race, age, hypertension, and diabetes did not modify associations of sodium with health outcomes. The committee concluded that, with the exception of heart failure, evidence of both benefit and harm is not strong enough to indicate that these subgroups should be treated differently from the general US population. Thus, the committee also concluded that evidence on direct health outcomes does not support recommendations to lower sodium intake within these subgroups to or even less than 1500 mg/d.

IMPLICATIONS FOR POPULATION-BASED STRATEGIES TO GRADUALLY REDUCE SODIUM INTAKE

Although not asked to specify targets for dietary sodium, the committee noted factors that precluded establishing these targets. These include lack of consistency in methods for defining sodium intakes at both high and low ends of typical intakes and extreme variability in intake levels across studies. The committee could only consider sodium intake levels within the context of each individual study because there were impediments to calibrating sodium assessment measures across studies.

After release of the IOM report, several news outlets highlighted disagreement among health agencies about targets for dietary sodium intake and reported that experts disagreed about the importance of blood pressure. Focusing the debate on specific targets misses the larger conclusion with which all are in agreement and may hinder implementation of important public health policy. Rather than focusing on disagreements about specific targets that currently affect less than 10% of the US population (ie, sodium intake of <2300 mg/d vs <1500 mg/d), the IOM, AHA, WHO, and DGA are congruent in suggesting that excess sodium intake should be reduced, and this is likely to have significant public health effects. Accomplishing such a reduction will require efforts to decrease sodium in the food environment10 and provide individual consumers more choice in their dietary consumption of sodium.

REFERENCES

1

Institute of Medicine.  Sodium Intake in Populations: Assessment of Evidence. Washington, DC: National Academies Press.http://www.iom.edu/Reports/2013/Sodium-Intake-in-Populations-Assessment-of-Evidence.aspx. May 2013. Accessed June 4, 2013

2

US Department of Agriculture and US Department of Health and Human Services.  Dietary Guidelines for Americans, 2010. 7th ed. Washington, DC: US Government Printing Office; 2010

3

Institute of Medicine.  Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate. Washington, DC: National Academies Press; 2005

4

Appel LJ, Frohlich ED, Hall JE,  et al.  The importance of population-wide sodium reduction as a means to prevent cardiovascular disease and stroke: a call to action from the American Heart Association.  Circulation. 2011;123(10):1138-1143
PubMed   |  Link to Article

5

World Health Organization.  Guideline: Sodium Intake for Adults and Children. Geneva, Switzerland: World Health Organization; 2012

6

Cogswell ME, Zhang Z, Carriquiry AL,  et al.  Sodium and potassium intakes among US adults: NHANES 2003-2008.  Am J Clin Nutr. 2012;96(3):647-657
PubMed   |  Link to Article

7

US Department of Agriculture and US Department of Health and Human Services.  Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans, 2010, to the Secretary of Agriculture and the Secretary of Health and Human Services. Washington, DC: USDA/ARS; 2010

8

Low sodium versus normal sodium diets in systolic heart failure: systematic review and meta-analysis [retraction]. heart.bmj.com/content/early/2013/03/12/heartjnl-2012-302337.extract. Accessed May 23, 2013

9

Aliti GB, Rabelo ER, Clausell N, Rohde LE, Biolo A, Beck-da-Silva L. Aggressive fluid and sodium restriction in acute decompensated heart failure: a randomized clinical trial.  JAMA Intern Med
PubMed  |  Link to Article

10

Institute of Medicine.  Strategies to Reduce Sodium Intake in the United States. Washington, DC: National Academies Press; 2010

Source: JAMA

Researchers assess multiple vitamin D doses in healthy breast-fed infants.


Researchers in Canada suggest that vitamin D supplementation of 1,600 IU per day increased plasma 25-hydroxyvitamin D concentrations to at least 75 nmol/L among 97.5% of infants aged 3 months. However, this dosage also increased concentrations associated with hypocalcemia, according to data.

The literature has established that vitamin D supplementation for infants is required to support healthy bone mineral accretion. However, conflicting recommendations for this patient population have led to further research.

“We have generated strong support using evidence-based dose response studies that the 400 IU dosage is quite satisfactory and that this is recommended now by the Institute of Medicine, Health Canada, Canadian Pediatric Society and the American Academy of Pediatrics,” researcher Hope Weiler, RD, PhD, of the School of Dietetics and Human Nutrition at McGill University in Quebec, said during a media telebriefing. “We also know that the higher dose recommended by the Canadian Pediatrics Society was well received by our infants and did generate a nice response in 25-hydroxyvitamin D, and the upper limits of 1,000 IU and 1,200 IU would be suitable as safety markers across the first year of life.”

According to data from a double blind, randomized study published in JAMA, Weiler and colleagues investigated the efficacy of various dosages of vitamin D supplements in supporting plasma 25-(OH)D concentrations in healthy, breast-fed infants (n=132) aged 1 month. The patients were randomly assigned to oral cholecalciferol (vitamin D3) supplements of 400 IU per day (n=39), 800 IU per day (n=39), 1,200 IU per day (n=38) or 1,600 IU per day (n=16), and they were followed for 11 months.

According to 3-month data, 55% (95% CI, 38-72) of infants in the 400-IU group demonstrated a 25-(OH)D concentration of at least 75 nmol/L vs. 81% (95% CI, 65-91) in the 800-IU group, 92% (95% CI, 77-98) in the 1,200-IU group and 100% in the 1,600-IU group. Due to elevations in 25-(OH)D concentrations, the 1,600 IU dosage was discontinued, researchers wrote. Moreover, the concentration did not continue in 97.5% of the infants at age 12 months in any of the groups.

Further data indicate that all dosages established 25-(OH)D concentrations of at least 50 nmol/L among 97% (95% CI, 94-100) of the infants at 3 months. This continued in 98% (95% CI, 94-100) at 12 months, the researchers wrote.

“Future studies should be larger and, hopefully, be able to detect early, as well as [determine], long-term benefits to bone. We may also consider other health benefits such as the immune system. Our future studies should consider other populations,” Weiler said. “We should also consider those at higher risk for deficiency, whether it’s due to geographic location where a mother’s exposure to sunshine is limited or the infant is born with vitamin D deficiency.”

In an accompanying editorial, Steven A. Abrams, MD, of the department of pediatrics at the US Department of Agriculture/Agricultural Research Service Children’s Nutrition Research Center at Baylor College of Medicine and Texas Children’s Hospital in Houston, said the study did not answer the question of what the target should be for plasma 25-(OH)D concentrations.

“Of importance, higher vitamin D dosages in this study did not lead to improved bone outcomes as reflected by DXA results for bone mineral content,” Abrams wrote.

He suggested that higher vitamin D intake and target plasma 25-(OH)D concentrations should be tested in clinical trials with markedly defined outcomes and precise safety monitoring.

 

Weiler H. JAMA. Theme Issue on Child Health: New research on the optimal dosing and possible adverse effects of different levels of vitamin D supplementation, important for bone health, for infants. Presented at: the JAMA Network 2013 Media Briefing; April 30, 2013; New York.

Disclosure: Abrams reports payment for lectures’/speakers’ bureaus from Mead-Johnson Nutrition and Abbott Nutrition and grants to his institution from Mead-Johnson Nutrition. Gallo reports travel support from CIHR Human Development Child and Youth Health and the American Society for Bone and Mineral Research. Sharma reports consulting fees for analyses prepared for Rodd and Weiler. Jones reports being cofounder and scientific advisory board member for Cytochroma Inc., and for receiving payment for speakers’ bureaus from Genzyme/Sanofi.

 

 

PERSPECTIVE

 

  • I  think it’s a helpful study in terms of the fact that they had different groups of newborn children treated with vitamin D with 400 IU being the recommended dose up to 12 months according to the Institute of Medicine and Endocrine Society guidelines. It was a well-designed study and relevant because vitamin D is a very hot topic right now due to the deficiencies in children and adults.

I agree with the editorial. This group of patients was a mostly white group with relatively high socioeconomic status. In the group that was administered 400 IU per day, researchers found that those infants reached 25(OH)D level of at least 20 ng/mL. That is a big debate. The IOM thinks 25(OH)D levels of 20 ng/mL are adequate for most, and I think a lot of endocrinologists and the Endocrine Society says most people need a level of 30 ng/mL.

This study shows that infants who were administered up to 400 IU per day reached a level of at least 20 ng/mL by 3 months. The whole group did not attain the level of 30 ng/mL, which again is what some endocrinologists think is an optimal level. To achieve a level of 30 ng/mL, perhaps 400 IU is not enough per day for some infants (especially those with darker skin pigmentation or at higher risk for deficiencies).

In addition to looking at the levels or how much vitamin D is needed to achieve a level of 20 ng/mL or 30 ng/mL, they also looked at the bone mineral content but found no significant difference in the groups. I think the editorial comment summed up this point. In treating infants with higher doses of vitamin D corresponding to higher serum levels above 30 ng/mL; does that confer other benefits? There are many early studies now looking at the relationship between vitamin D and asthma, food allergies, incidence of type 1 diabetes and autoimmune disease.

The important point Abrams raises is that we need more long-term studies to see if there is a skeletal benefit in terms of having a higher vitamin D level which would correspond to having a higher dose of vitamin D administered.

  • Dominique Noё Long, MD
  • Instructor of pediatric endocrinology
    The Johns Hopkins Children’s Center
    Baltimore, Md.

PERSPECTIVE

 

  • The strengths and usefulness of the study are the quantification of serum 25-OH vitamin D levels with various doses of vitamin D supplementation. The currently recommended dose of vitamin D, 400 IU daily, was chosen because historically this dose has proven to prevent rickets, which as pediatric endocrinologists, is our main objective. Therefore this study helps provide information in the ongoing debate regarding the optimal serum level of 25(OH) D. Interestingly, all doses of cholecalciferol increased serum levels of 25(OH) D to >50 nmol/L. Higher doses of cholecalciferol correlated with higher levels of 25(OH) D, however no group sustained >97.5% of infants to vitamin D levels >75 nmol/L. No one truly knows the ideal serum level of vitamin D, but this study suggests that >50 nmol/L was sufficient in this patient population. This study also provides information on the safety of higher doses of vitamin D supplementation. It may be harder to extrapolate in the darker-skin pigmented population who may need more vs. the white population. It’s just another piece to the puzzle of the debate on vitamin D.
  • Janet Crane, MD
  • Clinical research fellow in pediatric endocrinology
    The Johns Hopkins Children’s Center
    Baltimore, Md.

 

 

IOM: One Third of Healthcare Dollars Wasted .


Roughly one third of the money spent on U.S. healthcare in 2009 — about $750 billion — didn’t improve patients‘ health, according to an Institute of Medicine report released Thursday.

The report, Best Care at Lower Cost: The Path to Continuously Learning Health Care in America, outlined six categories of waste — unnecessary services, inefficient delivery of care, unnecessary administrative costs, inflated prices, missed opportunities for prevention, and fraud.

Among the group’s recommendations to help improve care while reducing cost:

  • Decision-support tools and knowledge management systems at point of care should be an integral part of the healthcare system.
  • Clinicians should use digital systems to capture patient care experiences.
  • Patients and caregivers should be encouraged to partner with clinicians in making healthcare decisions.
  • Clinicians should partner with community-based organizations and public health agencies to coordinate interventions to improve health, including use of Web-based tools.
  • The payment system should be reformed to reward quality care.

Source:Institute of Medicine