A clinical trial to evaluate the need for routine Vitamin D supplementation till six months age in full term babies who are being exclusively breastfed.
Phase 4
- Conditions
- Health Condition 1: null- Full term infants
- Registration Number
- CTRI/2015/08/006132
- Lead Sponsor
- Director Institute of Naval Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
1. Born at 37 weeks completed gestation or thereafter;
2. Birth weight equal to or more than 2500 gm;
3. Exclusively breastfed;
4. Parents provide written consent for their infant to participate in the study after detailed information is disseminated to them
Exclusion Criteria
1. Infants born before 37 completed weeks of gestation;
2. Low birth weight, i.e. birth weight less than 2500 gm;
3. Sick neonate, including birth asphyxia;
4. Neonate not exclusively breastfed from birth due to any reason even though may afterwards be on exclusive breastfeeds;
5. Neonates with major congenital anomalies, and,
6. Neonates whose parents decline consent to participate in the study.
(Presence of any one criterion will result in exclusion)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vitamin D levels in blood of study subjects as estimated by estimation of serum 25 hydroxy vitamin D (25OHD) level measured by radioimmunoassay using commercially available kitsTimepoint: 1. Levels in Umbilical Cord Blood at birth <br/ ><br>2. Levels at 1 month age <br/ ><br>3. Levels at 6 months age
- Secondary Outcome Measures
Name Time Method 1. Weight nearest to 10 gm, measured on a calibrated electronic weighing machine <br/ ><br>2. Length nearest to 0.5 cm measured on an infantometer <br/ ><br>3. Head circumference measured by a non-expansile tape measure to the nearest 0.5 cmTimepoint: 1. At Birth <br/ ><br>2. At 1 month <br/ ><br>3. At 6 months