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

Aga Khan University

Status: Completed

Conditions: Prematurity; Pre Eclampsia; Vitamin D Deficiency; Stillbirths; Low Birth Weight

Treatments: Dietary Supplement: Vitamin D; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01229189

Vitamin D Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 460 patients

Sex: Female

Ages: 15 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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460 participants in 2 patient groups, including a placebo group

Maternal and Neonatal Intervention Arm

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Vitamin D

Maternal and Neonatal Control Arm

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo