comparison of two doses of vitamin D in healthy term neonates
Not Applicable
- Registration Number
- CTRI/2020/11/029281
- Lead Sponsor
- PGIMER CHANDIGARH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1)Gestational age 37 weeks or more
2)Appropriate for gestation age (as defined by Intergrowth 21 growth charts) (32)
Exclusion Criteria
1)Families are not willing to follow-up at PGIMER.
2)Mother or infant on medications which can affect vitamin D metabolism (33) (Annexure-VII)
3)Mother is a known case of Chronic renal failure/ chronic liver failure/Parathyroid disorders
4)Major congenital malformations
5)Severe birth asphyxia (As defined by AAP/ACOG or need for chest compression)
6)Enteral feeding is not established by 48 hours of life.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method to compare proportions of vitamin D insufficieny in two groupsTimepoint: 14 weeks postnatal age
- Secondary Outcome Measures
Name Time Method 1.Incidence of maternal and neonatal vitamin D deficiency and insufficiency <br/ ><br>2.To compare the proportion of Vitamin D deficiency; biochemical parameters (serum Calcium, Phosphorous, ALP, PTH), anthropometry (Weight, Length, and Occipitofrontal circumference), adverse events related to vitamin D toxicity, and frequency of morbidities (episodes of respiratory illness, Hospitalization, seizure, etc) <br/ ><br>Timepoint: Outcome 1 at birth and rest at 14±2 weeks postnatal age