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Antenatal Vitamin D3 Dose-finding and Safety Study

NCT00938600 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2012-08-17

No results posted yet for this study

Summary

This is a preliminary study of oral vitamin D3 supplementation in pregnant and non-pregnant women of reproductive age in Bangladesh. The primary objective of the study is to identify a dose of vitamin D3 that can safely be administered during pregnancy to improve the vitamin D status of the mother and infant.

Conditions

  • Pregnancy
  • Nutritional Status
  • Vitamin D

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

Vitamin D3 oral liquid 70,000 IU once

DIETARY_SUPPLEMENT

Vitamin D3

Vitamin D3 oral liquid 70,000 IU as loading dose, then 35,000 IU weekly thereafter for 10 weeks (non-pregnant) or until delivery (pregnant)

DIETARY_SUPPLEMENT

Vitamin D3

Vitamin D3 14,000 IU per week by mouth, starting at 27-30 weeks gestation and continued until delivery.

Sponsors & Collaborators

Principal Investigators

  • Abdullah Baqui, MBBS · The Johns Hopkins Bloomberg School of Public Health

  • Rubhana Raqib, PhD · International Centre for Diarrhoeal Disease Research, Bangladesh

  • Shams El Arifeen, MBBS · International Centre for Diarrhoeal Disease Research, Bangladesh

  • Daniel E Roth, MD · The Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
34 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Bangladesh

Study Locations

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Entities

Companies

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 NCT00938600 on ClinicalTrials.gov