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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01229189
• Other study ID #: Vitamin D Study
• Status: Completed
• Phase: N/A
• First received: October 26, 2010
• Last updated: March 7, 2012
• Start date: February 2010
• Est. completion date: August 2011

Study information

• Verified date: March 2012
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Pakistan	Project Office Aga Khan University	Pind Dadan Khan	Punjab

Sponsors (2)

Lead Sponsor	Collaborator
Aga Khan University	John Snow, Inc.

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal and Neonatal complications	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	six months post enrolement	No
Secondary	Prevalence and Risk factors for Maternal and Neonatal Vit D Deficiency		Six months post recruitment	No

External Links

•   Official Website of the Aga Khan University