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
  Purpose

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.


Condition Intervention
Vitamin D Deficiency
Pre Eclampsia
Stillbirths
Low Birth Weight
Prematurity
Dietary Supplement: Vitamin D
Dietary Supplement: Placebo

Study Type: Interventional
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
Official Title: Evaluation of the Effectiveness of Vitamin D Supplementation to Pregnant Women and Their Infants in Pakistan

Resource links provided by NLM:


Further study details as provided by Aga Khan University:

Primary Outcome Measures:
  • 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


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

Enrollment: 460
Study Start Date: February 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229189

Locations
Pakistan
Project Office Aga Khan University
Pind Dadan Khan, Punjab, Pakistan, 49040
Sponsors and Collaborators
Aga Khan University
John Snow, Inc.
Investigators
Principal Investigator: Zulfiqar A Bhutta, FRCPCH, PhD Aga Khan University
  More Information

Additional Information:
No publications provided

Responsible Party: Dr Zulfiqar Ahmed Bhutta, Professor and Founding Chair, Division of Women and Child Health, Aga Khan University
ClinicalTrials.gov Identifier: NCT01229189     History of Changes
Other Study ID Numbers: Vitamin D Study
Study First Received: October 26, 2010
Last Updated: March 7, 2012
Health Authority: Pakistan: Ministry of Health

Keywords provided by Aga Khan University:
Vitamin D
Effectiveness
Pregnant women and their neonates

Additional relevant MeSH terms:
Birth Weight
Eclampsia
Pre-Eclampsia
Vitamin D Deficiency
Body Weight
Signs and Symptoms
Hypertension, Pregnancy-Induced
Pregnancy Complications
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 16, 2014