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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

September 12, 2005
November 9, 2010
August 2001
December 2004   (final data collection date for primary outcome measure)
Fetal loss, low birth weight and pre-term birth. [ Time Frame: Delivery ] [ Designated as safety issue: No ]
Fetal loss, low birth weight and pre-term birth.
Complete list of historical versions of study NCT00197548 on ClinicalTrials.gov Archive Site
Child morbidity and mortality; child growth [ Time Frame: 12 months postpartum ] [ Designated as safety issue: No ]
Child morbidity and mortality; child growth
Not Provided
Not Provided
 
A Trial of Micronutrients and Adverse Pregnancy Outcomes
A Trial of Micronutrients and Adverse Pregnancy Outcomes

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Pregnancy
  • Premature Birth
  • Infant, Low Birth Weight
  • Pregnancy Outcomes
  • 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.
  • 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.
  • Active Comparator: Multivitamins
    Multivitamins-vitamins B-complex, C, and E
    Intervention: Dietary Supplement: Multivitamins-vitamins B-complex, C, and E
  • Placebo Comparator: Placebo
    Placebo pill
    Intervention: Dietary Supplement: Placebo
Fawzi WW, Msamanga GI, Urassa W, Hertzmark E, Petraro P, Willett WC, Spiegelman D. Vitamins and perinatal outcomes among HIV-negative women in Tanzania. N Engl J Med. 2007 Apr 5;356(14):1423-31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8468
July 2006
December 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV negative
  • 12-26 weeks gestational age at screening visit
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00197548
HD37701
Yes
Wafaie Fawzi, Harvard School of Public of Health
Harvard School of Public Health
Muhimbili University of Health and Allied Sciences
Principal Investigator: Wafaie W Fawzi, MD,DrPh Harvard School of Public Health
Harvard School of Public Health
November 2010

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