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

• Sponsor: Aga Khan University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01229189
• Collaborator: John Snow, Inc. (Industry)
• Enrollment: 460
• Location: 1
• Arms: 2
• Duration (Months): 17.9
• Patients Per Site Per Month: 25.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency; Pre Eclampsia; Stillbirths; Low Birth Weight; Prematurity	Dietary Supplement: Vitamin D; Dietary Supplement: Placebo	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 460 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Maternal and Neonatal complications [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 Outcome Measures

1. Prevalence and Risk factors for Maternal and Neonatal Vit D Deficiency [Six months post recruitment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 49 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Official Website of the Aga Khan University

Publications

None provided.

• Responsible Party: Dr Zulfiqar Ahmed Bhutta, Professor and Founding Chair, Division of Women and Child Health, Aga Khan University
• ClinicalTrials.gov Identifier: NCT01229189
• Other Study ID Numbers: Vitamin D Study
• First Posted: Oct 27, 2010
• Last Update Posted: Mar 8, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by Dr Zulfiqar Ahmed Bhutta, Professor and Founding Chair, Division of Women and Child Health, Aga Khan University: Vitamin D; Effectiveness; Pregnant women and their neonates
• Additional relevant MeSH terms: Eclampsia; Pre-Eclampsia; Stillbirth; Vitamin D Deficiency; Birth Weight; Vitamin D

Study Results

No Results Posted as of Mar 8, 2012