Randomized controlled trial (RCT) of vitamin D supplementation in pregnancy in a population with endemic vitamin D deficiency
Dawodu A, Saadi HF, Bekdache G, Javed Y, Altaye M, Hollis BW
The Journal of clinical endocrinology and metabolism · 109 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
- Organización sin fines de lucro
- Thrasher Research Fund
Según 1 financiador declarado.
Publicación
- Publicado
- 2013-04-05 · J Clin Endocrinol Metab · vol. 98 · número 6 · págs. 2337–2346
- Editorial
- Oxford University Press
- Citado
- 180 citas · más que el 99% de estudios similares · 12.7× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 42 trabajos
- Acceso
- De pago
- Áreas de investigación
- Vitamin D Research Studies · Vitamin K Research Studies · Nutrition and Health Studies
- Palabras clave
- vitamin D supplementation, vitamin D deficiency, pregnancy, 25-hydroxyvitamin D, cord blood vitamin D, vitamin D sufficiency, dose comparison, Arab women
- MeSH
- humans, vitamin d deficiency, calcium, parathyroid hormone, vitamin d, double-blind method, pregnancy, dietary supplements, adult, female, outcome assessment, health care
6 autores
- Adekunle H. Dawodu🇺🇸 · autor de correspondenciaCincinnati Children's Hospital Medical Center
- Hussein Saadi
- Gharid Nourallah Bekdache🇦🇪United Arab Emirates University; Tawam Hospital
- Javed Yasin
- Mekibib Altaye🇺🇸Cincinnati Children's Hospital Medical Center
- Bruce W. Hollis🇺🇸Medical University of South Carolina
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Vitamin D (vD) deficiency in pregnancy is a global health problem and the amount of vD supplementation to prevent vD deficiency is controversial.
Objective
The objective of the study was to determine effectiveness and safety of prenatal 2000 IU and 4000 IU/d compared with 400 IU/d vD3 supplementation in a randomized controlled trial in population in which vD deficiency is endemic.
Design/methods
Arab women were randomized at 12-16 weeks of gestation to 400, 2000, and 4000 IU/d vD3, which were continued to delivery. Serum 25-hydroxyvitamin D [25(OH)D] concentrations were measured during pregnancy and at delivery. The primary outcome was the maternal and cord blood 25(OH)D, and the secondary outcomes were the achievement of sufficient serum 25(OH)D of 32 ng/mL or greater (≥80 nmol/L) at delivery.
Setting
The locations were primary care and tertiary perinatal care centers.
Results
Of 192 enrolled, 162 (84%) continued to delivery. Mean serum 25(OH)D of 8.2 ng/mL (20.5 nmol/L) at enrollment was low. Mean serum 25(OH)D concentrations at delivery and in cord blood were significantly higher in the 2000 and 4000 IU than the 400 IU/d group (P < .001) and was highest in the 4000 IU/d group. The percent who achieved 25(OH)D greater than 32 ng/mL and greater than 20 ng/mL concentrations in mothers and infants was highest in 4000 IU/d group. Safety measurements were similar by group and no adverse event related to vD supplementation.
Conclusions
Vitamin D supplementation of 2000 and 4000 IU/d appeared safe in pregnancy, and 4000 IU/d was most effective in optimizing serum 25(OH)D concentrations in mothers and their infants. These findings could apply to other populations in which vD deficiency is endemic.
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