CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 360 enrolled
Drug / intervention
600 IU Vitamin D3 in prenatal vitamin +2 moredietary
Likely dose
600 IU Vitamin D3 in prenatal vitaminfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02395081
NCT02395081N/ACompleted
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Trial of Vitamin D Supplements to Raise Calcidiol Levels of Pregnant Women in Mongolia

Brigham and Women's Hospital·interventional·Posted Mar 20, 2015·Updated Mar 23, 2021

In Brief

A clinical study evaluating 600 IU Vitamin D3 in prenatal vitamin, 2000 IU Vitamin D3 in prenatal vitamin, and 1 other intervention for Pregnancy and Vitamin D Deficiency. Completed, enrolled 360 participants across 1 site.

Detailed Summary

A double-blind randomized, placebo-controlled trial comparing the impact of 600 IU, 2000 IU, or 4000 IU of Vitamin D3 on third trimester 25(OH)D levels and change from baseline. The Vitamin D will be integrated in a standard prenatal vitamin, which will be taken from 12-16 weeks' gestation and continue throughout pregnancy. Umbilical cord 25(OH)D levels will also be determined. The investigators will generate preliminary data regarding Vitamin D intake and hypertensive disorders, blood pressure, and arterial function measured by tonography. The investigators will independently test blood pressure and proteinuria to identify preeclampsia cases.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy, Vitamin D Deficiency
CountriesMongolia
CollaboratorsNational Center for Maternal and Child Health, Mongolia, Zuun Kharaa Hospital

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 20, 2015
Enrollment StartFeb 1, 2015
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.3 years ago

Interventions

600 IU Vitamin D3 in prenatal vitamindietary

Women will receive 600 IU 25(OH)D in prenatal vitamin.

2000 IU Vitamin D3 in prenatal vitamindietary

Women will receive 2000 IU 25(OH)D in prenatal vitamin.

4000 IU Vitamin D3 in prenatal vitamindietary

Women will receive 4000 IU 25(OH)D in prenatal vitamin.