Status:
COMPLETED
Antenatal Vitamin D3 Dose-finding and Safety Study
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Pregnancy
Nutritional Status
Eligibility:
FEMALE
18-34 years
Phase:
PHASE1
Brief 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...
Detailed Description
Vitamin D deficiency is common among pregnant and non-pregnant Bangladeshi women. The consequences of vitamin D deficiency during pregnancy are unknown, but increasing evidence suggests it may comprom...
Eligibility Criteria
Inclusion
- Healthy women, age 18 to \< 35 years, who are clients at the Shimantik clinic or friends/relatives of Shimantik clients.
- Current permanent residence in Dhaka at a fixed address, and have plans to stay in Dhaka for at least 4 months.
- Pregnant women: Enrolled between 26th and 30th week of gestation (participants enrolled in 26th week will not start on-study until the 27th week or later), with a normal medical and obstetric history. Gestational age will be estimated based on the first day of the last menstrual period (LMP).
- Informed consent provided after having an opportunity to consult with husband and/or family members.
Exclusion
- Current self-reported use of any non-food-based dietary supplements containing vitamin D (i.e., commercial micronutrient pills or capsules containing vitamin D).
- Current use of anti-convulsant or anti-mycobacterial (tuberculosis) medications.
- Severe anemia (hemoglobin concentration \< 70 g/L).
- Hypertension (systolic blood pressure \>= 140 mmHg or diastolic blood pressure \>= 90 mmHg on at least two measurements).
- In pregnant women: previous history of giving birth to an infant with congenital anomalies.
- In non-pregnant women: currently breast-feeding.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00938600
Start Date
July 1 2009
End Date
June 1 2010
Last Update
August 17 2012
Active Locations (1)
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1
SHIMANTIK Maternity Centre
Dhaka, Dhaka Division, Bangladesh