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NCT Number: NCT01229189

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Death Deficiency Diseases Female Urogenital Diseases and Pregnancy Complications Fetal Death Hypertension, Pregnancy-Induced Low Birth Weight Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pre Eclampsia Pre-Eclampsia Pregnancy Complications Premature Birth Prematurity Stillbirth Stillbirths Urogenital Diseases

Age range

15 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Project Office Aga Khan University

Pind Dadan Khan, Punjab Province, 49040, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

Maternal dose of 4000 IU daily for 20 weeks Neonatal dose of 400 IU daily for 24 weeks

Placebo

Dietary Supplement

Placebo will be supplemented to pregnant women and their neonates in the same pattern as in intervention group.

Primary outcomes

  1. Maternal and Neonatal complications

    Time frame: six months post enrolement

    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 outcomes

  1. Prevalence and Risk factors for Maternal and Neonatal Vit D Deficiency

    Time frame: Six months post recruitment

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Collaborators

  • John Snow, Inc.

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 27, 2010
Registry last updated
Mar 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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