Journal of Nutrition & Food Sciences
Open Access
ISSN: 2155-9600
ISSN: 2155-9600
Myla D Ebeling
Tanzania
Research Article
Analysis of the NICHD Vitamin D Pregnancy Cohort on a Per-Protocol vs. Intent-to-Treat Basis: The Effect of Adherence on Trial Results
Author(s): Michael J Abercrombie, Judith R Shary, Myla D Ebeling, Bruce W Hollis and Carol L WagnerMichael J Abercrombie, Judith R Shary, Myla D Ebeling, Bruce W Hollis and Carol L Wagner
Objective: To perform per-protocol analysis of data obtained from the NICHD vitamin D pregnancy study published by Hollis et al., which found via intent-to-treat analysis that 4000IU/day vitamin D supplementation is safe and effective in achieving sufficiency in women and neonates. This study hypothesizes that differential adherence as examined by per-protocol analysis will affect the magnitude of differences in maternal and neonatal vitamin D status between treatment groups.
Study design: A double-blind, RCT of vitamin D supplementation (400, 2000 or 4000IU/day) in 350 Caucasian, African American and Hispanic women with singleton pregnancies was conducted. This study defines adherence as 75% and 85% of pills taken between visits and examines the effect of adherence on vitamin D status across treatment groups. The primary outcome, measured by r.. View More»
DOI:
10.4172/2155-9600.1000696