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

October 26, 2010
March 7, 2012
February 2010
August 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01229189 on ClinicalTrials.gov Archive Site
Prevalence and Risk factors for Maternal and Neonatal Vit D Deficiency [ Time Frame: Six months post recruitment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
  • Vitamin D Deficiency
  • Pre Eclampsia
  • Stillbirths
  • Low Birth Weight
  • Prematurity
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
460
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Female
15 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
Pakistan
 
NCT01229189
Vitamin D Study
Yes
Dr Zulfiqar Ahmed Bhutta, Aga Khan University
Aga Khan University
John Snow, Inc.
Principal Investigator: Zulfiqar A Bhutta, FRCPCH, PhD Aga Khan University
Aga Khan University
March 2012

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