NCT01229189

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 460 (actual)
• Sponsor: Aga Khan University · Academic / Other
• Sex: Female
• Age: 15 Years – 49 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vitamin D Deficiency
• Pre Eclampsia
• Stillbirths
• Low Birth Weight
• Prematurity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D	Maternal dose of 4000 IU daily for 20 weeks Neonatal dose of 400 IU daily for 24 weeks
DIETARY_SUPPLEMENT	Placebo	Placebo will be supplemented to pregnant women and their neonates in the same pattern as in intervention group.

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2010-10-27
• Last updated: 2012-03-08

Locations

1 site across 1 country: Pakistan