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Third study found that Infants needed 1600 IU of vitamin D – JAMA RCT May 2013

Effect of different dosages of oral vitamin D supplementation on vitamin D status in healthy, breastfed infants: a randomized trial.

JAMA. 2013 May 1;309(17):1785-92. doi: 10.1001/jama.2013.3404.
Gallo S, Comeau K, Vanstone C, Agellon S, Sharma A, Jones G, L'Abbé M, Khamessan A, Rodd C, Weiler H.
School of Dietetics and Human Nutrition, McGill University, Montréal, Québec, Canada.

IMPORTANCE: Vitamin D supplementation in infancy is required to support healthy bone mineral accretion. A supplement of 400 IU of vitamin D per day is thought to support plasma 25-hydroxyvitamin D (25[OH]D) concentrations between 40 and 50 nmol/L; some advocate 75 to 150 nmol/L for bone health.

OBJECTIVE: To investigate the efficacy of different dosages of vitamin D in supporting 25(OH)D concentrations in infants.

DESIGN, SETTING, AND PARTICIPANTS: Double-blind randomized clinical trial conducted among 132 one-month-old healthy, term, breastfed infants from Montréal, Québec, Canada, between March 2007 and August 2010. Infants were followed up for 11 months ending August 2011 (74% completed study).

INTERVENTION: Participants were randomly assigned to receive oral cholecalciferol (vitamin D3) supplements of

  • 400 IU/d (n=39),
  • 800 IU/d (n=39),
  • 1200 IU/d (n=38), or
  • 1600 IU/d (n=16).

MAIN OUTCOMES AND MEASURES: The primary outcome was a plasma 25(OH)D concentration of 75 nmol/L or greater in 97.5% of infants at 3 months.
Secondary outcomes included 25(OH)D concentrations of 75 nmol/L or greater in 97.5% of infants at 6, 9, and 12 months; 25(OH)D concentrations of 50 nmol/L or greater across all times; growth; and whole body and regional bone mineral content. Data were analyzed by intention to treat using available data, logistic regression, and mixed-model analysis of variance.

RESULTS: By 3 months, 55% (95% CI, 38%-72%) of infants in the 400-IU/d group achieved a 25(OH)D concentration of 75 nmol/L or greater vs 81%(95% CI, 65%-91%) in the 800-IU/d group, 92% (95% CI, 77%-98%) in the 1200-IU/d group, and 100% in the 1600-IU/d group. This concentration was not sustained in 97.5% of infants at 12 months in any of the groups. The 1600-IU/d dosage was discontinued prematurely because of elevated plasma 25(OH)D concentrations. All dosages established 25(OH)D concentrations of 50 nmol/L or greater in 97% (95% CI, 94%-100%) of infants at 3 months and sustained this in 98% (95% CI, 94%-100%) to 12 months. Growth and bone mineral content did not differ by dosage.

CONCLUSIONS AND RELEVANCE: Among healthy, term, breastfed infants, only a vitamin D supplement dosage of 1600 IU/d (but not dosages of 400, 800, or 1200 IU/d) increased plasma 25(OH)D concentration to 75 nmol/L or greater in 97.5% of infants at 3 months. However, this dosage increased 25(OH)D concentrations to levels that have been associated with hypercalcemia.

TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00381914.

Summary: 1600 IU vitamin D daily ==> 98% of infants > 30 ng

Vitamin D increases absorption of Calcium, which might result in hypercalcemia unless

  1. The amount of Calcium is reduced
  2. The amount of Magnesium is increased – so as to balance the body
  3. The amount of Vitamin K-2 is increased – so that the Calcium does not get into the wrong parts of the body

_Note: The serum level of vitamin D declined near the end of the trial_
This should not be a surprise.
The amount of vitamin D needed is proportional to body weight, and the infants gained weight over the year.
Dose/Response for 1200 IU and 1600 IU

PDF is attached at the bottom of this page


  • Future studies basing the dose on infant weight should reduced\s problems of too high of a response
  • Future studies should also use some of the cofactors - such as K-2 and Magnesium

Editorial: Targeting Dietary Vitamin D Intakes and Plasma 25-Hydroxyvitamin D in Healthy Infants

Note - the following is a result of OCR of the 1st page preview - there are several errors

PDF is available free at Sci-Hub   10.1001/jama.2013.4149

Steven A Abrams. MD
Vitamin D NUTRITION HAS BECOME ONE OF THE MOST widely discussed issues in modern medicine. Ongoing research has challenged traditional views of the role of vitamin D as limited to bone health. A large number of recent studies have raised compelling and as yet unanswered questions about optimal dietary intakes and outcomes related lo vitamin D. In infants and small children, it is well recognized that a severe deficiency of vitamin D can lead to rickets and related serious health problems including hypocalcemia, but little is known about other outcomes that are not related to bone or calcium.

A daily vitamin D intake of 400 IU/d has been demonstrated for almost 100 years to reliably prevent rickets in infants regardless of sunshine exposure or race.1 Although dietary recommendations have varied over time, a 2011 Institute of Medicine (lOM) report selected 400 IU/d as the adequate intake for infants younger than 1 year. 2 Unlike for older age groups, the IOM did not identify a true average requirement for vitamin D in infants (estimated average requirement) and the variation around that requirement needed lo calculate the better-known descriptor of intake, the recommended dietary allowance. 3 Whereas most adequate intakes for infants are based on the amount of a nutrient (eg. calcium) found in breast milk, this is not the case for vitamin D. The adequate intake was selected as 400 IU/d based on historical evidence that this dosage was safe and effective and the likelihood of achieving a plasma 25-hydroxyvitamin D (25|OH|D) concentration of 50 nmol/L with this dosage.

The selection of the adequate intake of 400 IU/d has not resolved controversies about vitamin D dosing in infants. One key issue has been whether the same dosage should be used for all infants, including preterm Infants, and for all ethnic and racial groups. It does not seem entirely satisfactory to recommend the same amount of dietary vitamin D for a 2.5-kg newborn infant, or an even smaller preterm infant, as for a 12-kg 11-month-old child, but data related to this distinction are limited and there is no basis for determining at what age or size during Infancy more vitamin I) might be needed.1, 3

Despite these uncertainties, it is reasonable to believe that plasma 25(OH)D concentration is the best marker of vitamin D exposure at any age 2 Therefore, information relating intake ol vitamin D to plasma 25(OH)D concentration is relevant to nutritional recommendations for vitamin D. Although some data are available evaluating plasma 25(OH)D concentration after providing breastfed infants 400 IU/d of supplemental vitamin D3. 3,4 the effects of a range of vitamin D dosages on 25(OM)D concentration is less clear. In particular, the IOM-established upper limit ol 1000 IU/d of vitamin D for infants (1500 IU/d for infants older than 6 months) has had little correlation with clinical outcomes, although toxicity concerns exist with high dosages in infants.'1

The randomized trial by Gallo and colleagues 6 in this issue of JAMA provides important dose-response information. In this clinical trial involving 132 healthy, term, 1 -month-old breastfed infants, the authors demonstrated that a supplemental vitamin D intake of 400 IU/d. as recommended by the IOM, met the target generally sought for nearly all children for plasma 25(OH)D concentration of at least 50 nmol/L (20 ng/mL) 3 but not the higher target of 75 umol/1. (30 ng/mL) recommended by others.7 The study also provides evidence that a vitamin D Intake of 1600 IU/d leads to a plasma 25(OH )D concentration greater than 250 nmol/I (100 ng/mL) in some infants, a level often considered toxic," although convincing data about a specific toxic plasma 25(OH)D concentration do not exist. Of importance, higher vitamin D dosages in this study did not lead to improved bone outcomes as reflected by dual-energy x-ray absorptiometry results for bone mineral content. This is not surprising. A substantial body of evidence in older children demonstrates no increase in calcium absorption efficiency, which is related to bone health, with plasma 25(OH)D concentration above 40 to 50 nmol/L 9 Although similar data do not exist for infants, there is no physiological reason to expect infants to require a higher plasma 25(OH)D concentration to absorb calcium than older children.1'1

The data reported by Gallo el al 6 do not answer the question of what the target should be for plasma 25(OH)D con-
End of free preview
Author Affiliation*: Department of Pediatrics. US Department of Agncufturc (USDA>/ Agricultural Research Service (ARS) Children's Nutrition Research Center. Baylor College ot Medicine, and Texas Children's Hospital. Houston. Corresponding Author Steven A. Abrams, MD. Department of Pediatrics. USDA/ ARS Children i Nutrition Research Center, Baylor College of Medicine. 1100 Bates St. Houston. TX 77030 (sabrams@bcm.edu>

Rebutal to comment about Rickets
Natural levels of vitamin D have dropped a lot in the past few decades

See also VitaminDWiki

Short url = http://is.gd/1600IU

Third study found that Infants needed 1600 IU of vitamin D – JAMA RCT May 2013        

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