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A Trial of Micronutrients and Adverse Pregnancy Outcomes

This study has been completed.
Sponsor:
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by:
Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT00197548
First received: September 12, 2005
Last updated: November 9, 2010
Last verified: November 2010
History of Changes
  Purpose

The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women.


Condition Intervention Phase
Pregnancy
Premature Birth
Infant, Low Birth Weight
Pregnancy Outcomes
 Dietary Supplement: Multivitamins-vitamins B-complex, C, and E
Dietary Supplement: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Trial of Micronutrients and Adverse Pregnancy Outcomes

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins
U.S. FDA Resources

Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • Fetal loss, low birth weight and pre-term birth. [ Time Frame: Delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Child morbidity and mortality; child growth [ Time Frame: 12 months postpartum ] [ Designated as safety issue: No ]

Enrollment: 8468
Study Start Date: August 2001
Study Completion Date: July 2006
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Multivitamins
Multivitamins-vitamins B-complex, C, and E
 Dietary Supplement: Multivitamins-vitamins B-complex, C, and E
One daily oral dose of 20 mg of B1, 20 mg of B2, 25 mg of B6, 100 mg of niacin, 50 mcg of B12, 500 mg of C, and 30 mg of vitamin E from randomization until delivery. Participants may continue taking this intervention until 18 months post-partum if they are re-randomized to it after delivery.
Placebo Comparator: Placebo
Placebo pill
 Dietary Supplement: Placebo
One daily oral dose of a placebo pill taken from randomization until delivery. Participants may continue taking this intervention until 18 months post-partum if they are re-randomized to it after delivery.

Detailed Description:

Fetal loss, low birth weight and preterm birth are major public health problems worldwide, particularly in developing countries. Birth outcomes are also major predictors of child health and survival in infancy and beyond. The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women. We also aim to determine whether the potentially protective effect of multivitamin supplements on the risks of low birth weight and preterm birth translate into a sustained reduction in infant mortality.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV negative
  • 12-26 weeks gestational age at screening visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197548

Sponsors and Collaborators
Harvard School of Public Health
Muhimbili University of Health and Allied Sciences
Investigators
Principal Investigator: Wafaie W Fawzi, MD,DrPh Harvard School of Public Health
  More Information

Publications:

Responsible Party: Wafaie Fawzi, Harvard School of Public of Health
ClinicalTrials.gov Identifier: NCT00197548     History of Changes
Other Study ID Numbers: HD37701
Study First Received: September 12, 2005
Last Updated: November 9, 2010
Health Authority: United States: Federal Government
Tanzania: Ministry of Health

Keywords provided by Harvard School of Public Health:
Women
Pregnancy Outcomes
Nutrition
 Vitamins
Tanzania
Maternal and Child Health Outcomes

Additional relevant MeSH terms:
Birth Weight
Premature Birth
Body Weight
Signs and Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Vitamin B Complex
Folic Acid
 Micronutrients
Vitamins
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 16, 2012