None listed
Conditions
Interventions
Intervention1: Vitamin D 400 IU ( 1 RDA): 400 IU (1 ml) daily given orally for 24 weeks
Control Intervention1: Placebo.: 1 ml daily given orally for 24 weeks
Sponsors
Department of Biotechnology
Translational Health Science and Technology Institute
Eligibility
Inclusion criteria
Inclusion criteria: 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 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 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
Exclusion criteria: 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 2. Birth weight 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| All antibody titres and quantitative outcomes will be analysed as four fold increases and as changes in geometric mean titres and absolute titres.Timepoint: 6, 10, 14 and 24 weeks;To determine if zinc deficiency in the infant (as assessed by serum zinc concentrations from cord blood and peripheral blood at 6, 10, 14 and 24 weeks) is associated with poor responses to vaccines.Timepoint: at 6 months (24 weeks);To determine the effect of daily vitamin D supplementation on growth, morbidity and survival of infants in the first 6 months of life.Timepoint: 0-6 months;To determine the effect of daily vitamin D supplementation on maturation of the immune system.Timepoint: 6, 10, 14 and 24 weeks;To determine the effect of daily vitamin D supplementation on polio specific IgA levels in serum of infants when compared to placeboTimepoint: at 6 months (24 weeks);To determine the effect of daily vitamin D supplementation on polio specific IgA levels in serum of infants when compared to placebo after each dose of immunization.Timepoint: at 6 months (24 weeks);To determine the effect of daily vitamin D supplementation on seroconversion to Hepatitis B immunization in infants when compared to placebo at 24 weeks and after each dose of Hepatitis B immunization.Timepoint: 6, 10 14 and 24 weeks;To determine the impact of daily vitamin D supplementation on â??post-BCG vaccinationâ?? response to tuberculin skin test in infants when compared to placebo at 24 weeks of age.Timepoint: at 6 months (24 weeks) | — |
Countries
India
Contacts
Public ContactUma chandra mouli Natchu
THSTI
Outcome results
None listed