In moderate and late preterm newborns supplementation of postpartum mothers with vitamin D3 to achieve adequate levels of vitamin D in these newborns versus the routine supplementation of the newborns receiving Mothers Own Milk. A 3 month follow up randomized trial
- Conditions
- Health Condition 1: E559- Vitamin D deficiency, unspecified
- Registration Number
- CTRI/2023/05/052822
- Lead Sponsor
- AIIMS Jodhpur
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Newborn babies of equal to or greater than 32 weeks of post-menstrual age till 37 completed weeks will be included with birth weight appropriate for gestational age as recorded on Fenton growth chart
The newborn will be excluded from the trial if they have-
1. Gross Congenital anomaly
2. With chromosomal anomaly
3. on formula feeds
The mothers will be excluded if they are suffering from chronic diseases like tuberculosis, chronic liver disease, chronic kidney disease, HIV, hepatitis B, or those who have received vitamin D in the last 3 months apart from Tab Osteocalcium (elemental calcium 500 mg and vitamin D3 250 IU) given during the national antenatal program.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum 25(OH) vitamin D levelsTimepoint: at 12 weeks of postnatal age
- Secondary Outcome Measures
Name Time Method Maternal compliance with vitamin D3 therapyTimepoint: at 12 weeks of PostNatal Age;The proportion of children with- <br/ ><br>Biochemical Changes- <br/ ><br>1) Hypocalcemia <br/ ><br>2) Hypophosphatemia <br/ ><br>3) Hypercalcemia <br/ ><br>4 ) Raised serum alkaline phosphataseTimepoint: At 40 weeks of Postmenstrual age and at 12 weeks of Post Natal Age