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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Low Birth Weight; Pre Eclampsia; Prematurity; Stillbirths
• Intervention / Treatment: Dietary supplement: Vitamin D; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 460
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Pind Dadan Khan, Punjab, Pakistan, 49040
      • Project Office Aga Khan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maternal and Neonatal Intervention Arm; 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.	Dietary supplement: Vitamin D; Maternal dose of 4000 IU daily for 20 weeks Neonatal dose of 400 IU daily for 24 weeks
Placebo Comparator: Maternal and Neonatal Control Arm	Dietary supplement: Placebo; Placebo will be supplemented to pregnant women and their neonates in the same pattern as in intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Prevalence and Risk factors for Maternal and Neonatal Vit D Deficiency	Six months post recruitment

Collaborators and Investigators

• Sponsor: Aga Khan University
• Collaborators: John Snow, Inc.

Publications and helpful links

General Publications

• 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.

Helpful Links

• Official Website of the Aga Khan University

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: October 26, 2010
• First Submitted That Met QC Criteria: October 26, 2010
• First Posted (Estimate): October 27, 2010

Study Record Updates

• Last Update Posted (Estimate): March 8, 2012
• Last Update Submitted That Met QC Criteria: March 7, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Vitamin D; Effectiveness; Pregnant women and their neonates
• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Body Weight; Avitaminosis; Deficiency Diseases; Malnutrition; Pregnancy Complications; Death; Hypertension, Pregnancy-Induced; Fetal Death; Vitamin D Deficiency; Birth Weight; Eclampsia; Pre-Eclampsia; Stillbirth; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: Vitamin D Study