EFFECT OF ORAL VITAMIN D SUPPLEMENTATION TO LACTATING MOTHERS ON DEVELOPMENT OF RICKETS IN EXCLUSIVELY BREASTFED INFANTS- AN OPEN LABEL RANDOMISED CONTROLLED TRIA
Not Applicable
- Registration Number
- CTRI/2023/07/055303
- Lead Sponsor
- Dr Nishi gupta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Exclusively breastfed or predominantly breastfed infants
Term (37-41completed weeks) and appropriate for gestational age (AGA)
Does not have any gross congenital anomalies, neonatal sepsis, HIE 11, 111
Not on Vitamin D supplementation
Exclusion Criteria
Infants with history of birth asphyxia.
Infants with history of any congenital anomaly
Infants with neonatal sepsis or history of any blood transfusion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method We will find out proportion of exclusively breastfed infants developing rickets at 6 months of age with or without Vitamin D3 supplementation to lactating mothers <br/ ><br> <br/ ><br>We will find out proportion of exclusively breastfed infants with 25(OH)D levels 11ng/dl at 6 months of age with or without Vitamin D3 supplementation to lactating mothers. <br/ ><br>Timepoint: At 6 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method We will estimate serum calcium, phosphate levels at 6 months of age with or without Vitamin D supplementation to lactating mothers. <br/ ><br>Timepoint: 6 months