CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 501 enrolled
Drug / intervention
cholecalciferol (vitamin D3) +1 moredrug
Likely dose
Cholecalciferol (vitamin D3) 400, 2000, or 4000 IU/dayAI-extracted
Key inclusion· 3
  • Women aged 16–45 years
  • In good general health
  • Less than 12 weeks pregnant (based on last menstrual period)
Key exclusion· 4
  • Preexisting type I or type II diabetes
  • Preexisting hypertension
  • Preexisting parathyroid disease or uncontrolled thyroid disease
  • Multiple fetuses (twins, triplets, etc.)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00292591
NCT00292591Phase 3Completed

Evaluation of Vitamin D Requirements During Pregnancy

Medical University of South Carolina·interventional·Posted Feb 16, 2006·Updated Sep 19, 2016

In Brief

A Phase 3 clinical trial evaluating cholecalciferol (vitamin D3) and cholecalciferol for Vitamin D Deficiency. Completed, enrolled 501 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the effectiveness of vitamin D supplementation during pregnancy starting at the beginning of the second trimester. Mothers will be randomized to one of three vitamin D dosing groups: 400, 2,000 or 4,000 international units per day. It is hypothesized that the highest dosing regimen will result in a better vitamin D status of women regardless of their ethnicity or race.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 16, 2006
Enrollment StartJan 1, 2004
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 20.4 years ago

Interventions

cholecalciferol (vitamin D3)drug

randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day

cholecalciferoldrug

comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy