Evaluation of the Effectiveness of Vitamin D Supplementation to Pregnant Women and Their Infants in Pakistan.
NCT01229189 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 460
Last updated 2012-03-08
Summary
Vitamin D deficiency is wide spread in South Asian population and is contributing to burden of disease in this region including Pakistan. The relative importance of vitamin D deficiency, mutation in its receptor and maternal and child health has not been established in Pakistan and population based studies are required to explore and avert the maternal and Neonatal complications and consequences of Vitamin D deficiency
The trial will evaluate the effectiveness of Vitamin D supplementation to pregnant women and their Infants. It will be a double blind placebo controlled trial, which will be conducted in a rural district of Pakistan.
Conditions
- Vitamin D Deficiency
- Pre Eclampsia
- Stillbirths
- Low Birth Weight
- Prematurity
Interventions
- DIETARY_SUPPLEMENT
-
Vitamin D
Maternal dose of 4000 IU daily for 20 weeks Neonatal dose of 400 IU daily for 24 weeks
- DIETARY_SUPPLEMENT
-
Placebo
Placebo will be supplemented to pregnant women and their neonates in the same pattern as in intervention group.
Sponsors & Collaborators
-
John Snow, Inc.
collaborator INDUSTRY -
Aga Khan University
lead OTHER
Principal Investigators
-
Zulfiqar A Bhutta, FRCPCH, PhD · Aga Khan University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- QUADRUPLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 15 Years
- Max Age
- 49 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-02-28
- Primary Completion
- 2011-08-31
- Completion
- 2011-08-31
Countries
- Pakistan
Study Locations
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