Health characteristics and outcomes of two randomized vitamin D supplementation trials during pregnancy: A combined analysis

▸ Two randomized clinical trial pregnancy vitamin D datasets were combined for analysis. ▸ No differences in baseline 25(OH)D were noted between groups. ▸ Maternal/cord blood 25(OH)D greatest in 4000IU group. ▸ Comorbidities of pregnancy were strongly associated with vitamin D status. To assess the...

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Bibliographic Details
Published in:The Journal of steroid biochemistry and molecular biology 2013-07, Vol.136, p.313-320
Main Authors: Wagner, Carol L., McNeil, Rebecca B., Johnson, Donna D., Hulsey, Thomas C., Ebeling, Myla, Robinson, Christopher, Hamilton, Stuart A., Hollis, Bruce W.
Format: Article
Language:English
Subjects:
Cholecalciferol
Dietary Supplements
Double-Blind Method
Ergocalciferols - administration & dosage
Female
Health outcomes
Humans
Infant, Newborn
Pregnancy
Pregnancy Complications - prevention & control
Prenatal Care
Randomized Controlled Trials as Topic - trends
Vitamin D
Vitamin D - analogs & derivatives
Vitamin D - blood
Vitamin D Deficiency - complications
Vitamin D Deficiency - prevention & control
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Summary:▸ Two randomized clinical trial pregnancy vitamin D datasets were combined for analysis. ▸ No differences in baseline 25(OH)D were noted between groups. ▸ Maternal/cord blood 25(OH)D greatest in 4000IU group. ▸ Comorbidities of pregnancy were strongly associated with vitamin D status. To assess the safety and health effects of vitamin D supplementation during pregnancy. Datasets from two randomized clinical trials were first analyzed separately then combined for this analysis using a common data dictionary. In the NICHD trial, women were randomized to 400, 2000, or 4000IU vitamin D3/day, stratified by race. In the Thrasher Research Fund trial, participants were randomized to 2000 or 4000IU vitamin D3/day. Study drugs were from the same manufacturing lot for both trials. Identical questionnaires were given for comparable sociodemographics & clinical characteristics. Outcome measures were: [1] maternal and neonatal 25(OH)D achieved, and [2] maternal comorbidities of pregnancy (COP). SAS 9.3 was used for all analyses. In the combined cohort, there were 110 controls, 201 in the 2000IU group, and 193 in the 4000IU group. No differences between groups in baseline 25(OH)D were found; however, delivery and cord blood values were greater in the 4000IU group (p
ISSN:0960-0760
1879-1220
DOI:10.1016/j.jsbmb.2013.01.002