A study of the effect of vitamin D supplementation in pregnant women, on the growth and biochemical features of the newborn baby and infant.
Phase 3
Completed
- Registration Number
- CTRI/2010/091/000499
- Lead Sponsor
- Department of endocrinology, SGPGIMS, Lucknow
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
All pregnant women who attend antenatal clinic of one unit of Queen Mary Hospital, Chhatrapati Sahuji Maharaj Medical University, Lucknow, are recruited as subjects and randomised to receive one of the 2 intervention regimes. Consecutive women who attend antenatal clinic too near term to be included in the study to serve as controls.
Exclusion Criteria
Patients already on calcium or on vitamin D supplementation, on anticonvulsants, on antitubercular treatment or having any medical condition affecting calcium and vitamin D metabolism (e.g. renal or liver disease).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eonatal serum calciumTimepoint: At 4 to 6 day of life
- Secondary Outcome Measures
Name Time Method Baby weight, length, head circumference, anterior fontanelle diameterTimepoint: 3 month of age;Baby weight, length, head circumference, anterior fontanelle diameterTimepoint: Birth;Baby weight, length, head circumference, anterior fontanelle diameterTimepoint: Nine month of age;Baby weight, length, head circumference, anterior fontanelle diameterTimepoint: Six month of age;Cord blood 25 OHD3Timepoint: Birth;Cord blood alkaline phosphataseTimepoint: Birth