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Trial of Vitamin D Supplements to Raise Calcidiol Levels of Pregnant Women in Mongolia

NCT02395081 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2021-03-23

Study results available
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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.

Conditions

  • Pregnancy
  • Vitamin D Deficiency

Interventions

DIETARY_SUPPLEMENT

600 IU Vitamin D3 in prenatal vitamin

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

DIETARY_SUPPLEMENT

2000 IU Vitamin D3 in prenatal vitamin

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

DIETARY_SUPPLEMENT

4000 IU Vitamin D3 in prenatal vitamin

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

Sponsors & Collaborators

  • National Center for Maternal and Child Health Research, Mongolia

    collaborator UNKNOWN

  • Zuun Kharaa Hospital

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Janet Rich-Edwards, ScD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Mongolia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02395081 on ClinicalTrials.gov