Evaluation of the Effectiveness of Vitamin D Supplementation to Pregnant Women and Their Infants in Pakistan.

Not Applicable

Completed

• Conditions: Vitamin D Deficiency; Pre Eclampsia; Stillbirths; Low Birth Weight; Prematurity
• Interventions: Dietary Supplement: Vitamin D; Dietary Supplement: Placebo

• Registration Number: NCT01229189
• Lead Sponsor: Aga Khan University

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 Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-10-26
• Study First Submitted QC: 2010-10-26
• Study First Posted: 2010-10-27
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 460

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Maternal and Neonatal Intervention Arm	Vitamin D	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.
Maternal and Neonatal Control Arm	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Prevalence and Risk factors for Maternal and Neonatal Vit D Deficiency	Six months post recruitment

Trial Locations

Locations (1)

Project Office Aga Khan University; 🇵🇰 Pind Dadan Khan, Punjab, Pakistan