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

Primary Purpose

Vitamin D Deficiency, Pre Eclampsia, Stillbirths

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Vitamin D
Placebo
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Vitamin D Deficiency focused on measuring Vitamin D, Effectiveness, Pregnant women and their neonates

Eligibility Criteria

15 Years - 49 Years (Child, Adult)FemaleDoes not accept 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

Sites / Locations

  • Project Office Aga Khan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Maternal and Neonatal Intervention Arm

Maternal and Neonatal Control Arm

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Prevalence and Risk factors for Maternal and Neonatal Vit D Deficiency

Full Information

First Posted
October 26, 2010
Last Updated
March 7, 2012
Sponsor
Aga Khan University
Collaborators
John Snow, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01229189
Brief Title
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

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
Collaborators
John Snow, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Pre Eclampsia, Stillbirths, Low Birth Weight, Prematurity
Keywords
Vitamin D, Effectiveness, Pregnant women and their neonates

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
460 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maternal and Neonatal Intervention Arm
Arm Type
Experimental
Arm 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.
Arm Title
Maternal and Neonatal Control Arm
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
Maternal dose of 4000 IU daily for 20 weeks Neonatal dose of 400 IU daily for 24 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo will be supplemented to pregnant women and their neonates in the same pattern as in intervention group.
Primary Outcome Measure Information:
Title
Maternal and Neonatal complications
Description
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
Time Frame
six months post enrolement
Secondary Outcome Measure Information:
Title
Prevalence and Risk factors for Maternal and Neonatal Vit D Deficiency
Time Frame
Six months post recruitment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zulfiqar A Bhutta, FRCPCH, PhD
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Project Office Aga Khan University
City
Pind Dadan Khan
State/Province
Punjab
ZIP/Postal Code
49040
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
33305842
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.
Results Reference
derived
Links:
URL
http://www.aku.edu
Description
Official Website of the Aga Khan University

Learn more about this trial

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

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