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

NCT01229189 | Completed DMC

• 1 other identifier: Vitamin D Study
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Pre Eclampsia; Stillbirths; Low Birth Weight; Prematurity

Keywords

Vitamin D; Effectiveness; Pregnant women and their neonates

Outcome Measures

Primary Outcomes (1)

• 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

  six months post enrolement

Secondary Outcomes (1)

• Prevalence and Risk factors for Maternal and Neonatal Vit D Deficiency

  Six months post recruitment

Study Arms (2)

Maternal and Neonatal Intervention Arm

EXPERIMENTAL

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 and Neonatal Control Arm

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Vitamin D DIETARY_SUPPLEMENT

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

Maternal and Neonatal Intervention Arm

Placebo DIETARY_SUPPLEMENT

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

Maternal and Neonatal Control Arm

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women from 20-22 weeks of gestation and their infants, who will agree to take part in this study, will be enrolled.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead
• John Snow, Inc.: collaborator

Study Sites (1)

Project Office Aga Khan University

Pind Dadan Khan, Punjab Province, 49040, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 33305842 DERIVED

Related Links

• Official Website of the Aga Khan University

MeSH Terms

Conditions

Vitamin D Deficiency; Pre-Eclampsia; Stillbirth; Premature Birth

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Zulfiqar A Bhutta, FRCPCH, PhD

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Founding Chair, Division of Women and Child Health

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: October 27, 2010
• Study Start: February 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 8, 2012

Record last verified: 2012-03

Locations

PA (1)