Clinical trial NCT01229189: Evaluation of the Effectiveness of Vitamin D Supplementation to Pregnant Women and Their Infants in Pakistan.
Official title: Evaluation of the Effectiveness of Vitamin D Supplementation to Pregnant Women and Their Infants in Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Pre Eclampsia
Stillbirths
Low Birth Weight
Prematurity
Keywords: Vitamin D
Effectiveness
Pregnant women and their neonates
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: John Snow, Inc.
First posted: 2010-10-27
Enrollment: 460
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maternal and Neonatal complications
timeFrame: six months post enrolement
Secondary outcomes:
measure: Prevalence and Risk factors for Maternal and Neonatal Vit D Deficiency
timeFrame: Six months post recruitment
Other outcomes:
Locations:
city: Pind Dadan Khan
country: Pakistan
facility: Project Office Aga Khan University
state: Punjab
Study officials:
affiliation: Aga Khan University
name: Zulfiqar A Bhutta, FRCPCH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.