Effect of different dosages of oral vitamin D supplementation on vitamin D status in healthy, breastfed infants: a randomized trial
Gallo S, Comeau K, Vanstone C, Agellon S, Sharma A, Jones G, L'Abbé M, Khamessan A, Rodd C, Weiler H
JAMA · 148 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- Canadian Institutes of Health Research
Según 1 financiador declarado.
Publicación
- Publicado
- 2013-05-01 · JAMA · vol. 309 · número 17 · pág. 1785
- Editorial
- American Medical Association
- Citado
- 205 citas · más que el 100% de estudios similares · 18.9× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 30 trabajos
- Acceso
- De pago
- Áreas de investigación
- Vitamin D Research Studies · Vitamin K Research Studies · Bone health and osteoporosis research
- Palabras clave
- vitamin D supplementation, vitamin D dosage, 25-hydroxyvitamin D, breast-fed infants, vitamin D3, vitamin D status, bone mineral content, infant growth, bone mineral accretion, vitamin D deficiency prevention, healthy term infants, vitamin D2 supplementation, vitamin D toxicity, 25-hydroxyvitamin D2, 25-hydroxyvitamin D3
- MeSH
- humans, hypercalcemia, cholecalciferol, vitamins, vitamin d, treatment outcome, administration, oral, double-blind method, breast feeding, bone development, dose-response relationship, drug, infant, infant, newborn, female, male, infant nutritional physiological phenomena
10 autores
- Sina Gallo🇨🇦McGill University
- Kathryn Comeau
- Catherine A. Vanstone
- Sherry Agellon
- Atul Kumar Sharma
- Glenville Jones
- Mary R. L’Abbé
- Ali Khamessan
- Celia J. Rodd
- Hope Alberta Weiler · autor de correspondencia
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
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