Evaluation of the Effectiveness of Vitamin D Supplementation to Pregnant Women and Their Infants in Pakistan
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Aga Khan University
- Enrollment
- 460
- Locations
- 1
- Primary Endpoint
- Maternal and Neonatal complications
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 15 Years to 49 Years (Child, Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
Maternal and Neonatal Control Arm
Intervention: Placebo (Dietary Supplement)
Maternal and Neonatal Intervention Arm
Pregnant women will be individually randomized; a daily dose of vitamin D in 4000 IU will be given to Intervention group, started at 20-22 weeks of pregnancy till the time of delivery. The infants of this group will further stratify into two groups, one group will receive 400 IU of Vitamin D for 6 months as Intervention.
Intervention: Vitamin D (Dietary Supplement)
Outcomes
Primary Outcomes
Maternal and Neonatal complications
Time Frame: 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 Outcomes
- Prevalence and Risk factors for Maternal and Neonatal Vit D Deficiency(Six months post recruitment)
Investigators
Dr Zulfiqar Ahmed Bhutta
Professor and Founding Chair, Division of Women and Child Health
Aga Khan University