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A Trial of Micronutrients and Adverse Pregnancy Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00197548
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 11, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Pregnancy Premature Birth Infant, Low Birth Weight Pregnancy Outcomes Dietary Supplement: Multivitamins-vitamins B-complex, C, and E Dietary Supplement: Placebo Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Trial of Micronutrients and Adverse Pregnancy Outcomes
Study Start Date : August 2001
Primary Completion Date : December 2004
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Fetal loss, low birth weight and pre-term birth. [ Time Frame: Delivery ]

Secondary Outcome Measures :
  1. Child morbidity and mortality; child growth [ Time Frame: 12 months postpartum ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV negative
  • 12-26 weeks gestational age at screening visit
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 11, 2010
Last Verified: November 2010

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
Vitamins
Folic Acid
Vitamin B Complex
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Hematinics