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

Abstract

Objective-To assess the safety and health effects of vitamin D supplementation during pregnancy.Methods and Design-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 4000 IU vitamin D 3 /day, stratified by race. In the Thrasher Research Fund trial, participants were randomized to 2000 or 4000 IU vitamin D 3 /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.Results-In the combined cohort, there were 110 controls, 201 in the 2000 IU group, and 193 in the 4000 IU group. No differences between groups in baseline 25(OH)D were found; however, delivery and cord blood values were greater in the 4000 IU group (p<0.0001), an effect that persisted even after controlling for race and study. A greater percent were vitamin D replete in the 4000 IU group (p<0.0001). There was a trend where the 4000 IU group had decreased rates of Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. HHS Public Access

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