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 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.

Results<

SUBMITTER: Wagner CL 

PROVIDER: S-EPMC4365419 | biostudies-literature | 2013 Jul

REPOSITORIES: biostudies-literature