Low Birth Weight, Pre Eclampsia, Prematurity, Stillbirths, Vitamin D Deficiency
Conditions
Keywords
Vitamin D, Effectiveness, Pregnant women and their neonates
Brief summary
Vitamin D deficiency is wide spread in South Asian population and is contributing to burden of disease in this region including Pakistan. The relative importance of vitamin D deficiency, mutation in its receptor and maternal and child health has not been established in Pakistan and population based studies are required to explore and avert the maternal and Neonatal complications and consequences of Vitamin D deficiency The trial will evaluate the effectiveness of Vitamin D supplementation to pregnant women and their Infants. It will be a double blind placebo controlled trial, which will be conducted in a rural district of Pakistan.
Detailed description
The investigators are proposing a community based introduction of vitamin D supplementation and we intend to understand the complex relationship between vitamin D, the growth factors and maternal and infant anthropometric variables and hope to unravel the reasons of vitamin D deficiency in our population. The investigators expect that if vitamin D is supplemented to pregnant women and their newborn infants it will inevitably replenish the micronutrient stores and aid to resolve the maternal and neonatal morbidity due to Vitamin D deficiency.
Interventions
DIETARY_SUPPLEMENTVitamin D
Maternal dose of 4000 IU daily for 20 weeks Neonatal dose of 400 IU daily for 24 weeks
DIETARY_SUPPLEMENTPlacebo
Placebo will be supplemented to pregnant women and their neonates in the same pattern as in intervention group.
Sponsors
John Snow, Inc.
Aga Khan University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant women from 20-22 weeks of gestation and their infants, who will agree to take part in this study, will be enrolled.
Exclusion criteria
* Pregnant women with pre existing type 1 or type II diabetes * Women with multiple fetuses, babies (twins, triplets) * Pregnant women with high level of Vitamin D * Babies with multiple congenital anomalies * Babies with serious birth injury, birth asphyxia and serious infections * Low birth weight less than 1.5 * Refuse to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal and Neonatal complications | six months post enrolement | Preeclampsia, hypertension ,poor weight gain etc during pregnancy.Still birth rates, Rate of low birth weight, prematurity,Neonatal seizures, Infants with growth failure, signs and symptoms of vitamin D deficiency. Infants with infections: pneumonia, diarrhea and Receptor polymorphism |
Secondary
| Measure | Time frame |
|---|---|
| Prevalence and Risk factors for Maternal and Neonatal Vit D Deficiency | Six months post recruitment |
Countries
Pakistan
Outcome results
None listed