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

This study has been completed.

Sponsor:

Collaborator:

John Snow, Inc.

Information provided by (Responsible Party):

Dr Zulfiqar Ahmed Bhutta, Aga Khan University

ClinicalTrials.gov Identifier:

NCT01229189

First received: October 26, 2010

Last updated: March 7, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 26, 2010

Last Updated Date

March 7, 2012

Start Date ^ICMJE

February 2010

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Maternal and Neonatal complications [ Time Frame: six months post enrolement ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01229189 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Prevalence and Risk factors for Maternal and Neonatal Vit D Deficiency [ Time Frame: Six months post recruitment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Vitamin D Deficiency
Pre Eclampsia
Stillbirths
Low Birth Weight
Prematurity

Intervention ^ICMJE

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

Study Arm (s)

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.

Intervention: Dietary Supplement: Vitamin D
Placebo Comparator: Maternal and Neonatal Control Arm
Intervention: Dietary Supplement: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

460

Completion Date

August 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

15 Years to 49 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Pakistan

Administrative Information

NCT Number ^ICMJE

NCT01229189

Other Study ID Numbers ^ICMJE

Vitamin D Study

Has Data Monitoring Committee

Yes

Responsible Party

Dr Zulfiqar Ahmed Bhutta, Aga Khan University

Study Sponsor ^ICMJE

Aga Khan University

Collaborators ^ICMJE

John Snow, Inc.

Investigators ^ICMJE

Principal Investigator:

Zulfiqar A Bhutta, FRCPCH, PhD

Aga Khan University

Information Provided By

Aga Khan University

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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