Vitamin D supplementation and responses to vaccines in infants
- Registration Number
- CTRI/2013/04/003566
- Lead Sponsor
- Department of Biotechnology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 900
Pregnant women will be checked for inclusion criteria during pregnancy & labour, after birth when breastfeeding is established within the first 24 hours.
Inclusion criteria during pregnancy and labour are:
1. Pregnant at any gestation when screened antenatally; Pregnancy full term ( > 37 and < 41 completed weeks) when screened again at labour (consent will only be taken in the antenatal period and not during labour)
2. Will stay in study area for a period of at least 6 months after delivery
3. Delivery by vaginal route or by elective cesarian section
Inclusion criteria at birth and within 24 hours:
1. Single term newborn (gestational age > 37 and < 41 weeks at birth) < 24 hours old.
2. Born by normal vaginal route or elective caesarean section.
3. Will stay in study area for a period of atleast 6 months after delivery
4. Breastfeeding established.
Exclusion criteria during pregnancy and intrapartum period.
1. A mother with a history of > 5 pregnancies.
2. Multiple gestation.
3. Presence of any documented major maternal medical or surgical illness e.g. HIV, Hepatitis B, Tuberculosis, TORCH infections, syphilis, malignancy or immunodeficiency, etc.
4. Presence of fetal (major) congenital anomalies diagnosed in utero.
5. Any infection during pregnancy that required hospitalization.
6. Blood transfusion during pregnancy.
7. History of maternal eclampsia / preeclampsia / hypertension with significant proteinuria ( > 3+) during pregnancy.
Exclusion criteria at birth and within 24 hrs:
1. One minute Apgar of < 7/10.
2. Birth weight < 1.8 kg.
3. Multiple gestation.
4. Major congenital anomalies diagnosed prior to birth or during a clinical examination by a
pediatrician performed within the first 24 hours.
5. Newborn required admission to neonatal intensive care prior to randomization.
6. Informed written consent not provided by parents.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the effect of daily vitamin D supplementation on seroconversion to Oral Polio Vaccine (as measured by a four fold increase in serum polio specific IgA antibodies to serotype 3) in infants when compared to placebo.Timepoint: At 24 weeks of age
- Secondary Outcome Measures
Name Time Method