A Trial of Micronutrients and Adverse Pregnancy Outcomes

Pregnancy Clinical Trial

Official title:

A Trial of Micronutrients and Adverse Pregnancy Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197548
• Other study ID #: HD37701
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: November 9, 2010
• Start date: August 2001
• Est. completion date: July 2006

Study information

• Verified date: November 2010
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentTanzania: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8468
• Est. completion date: July 2006
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV negative

• 12-26 weeks gestational age at screening visit

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Birth Weight
• Infant, Low Birth Weight
• Pregnancy
• Pregnancy Outcomes
• Premature Birth

Intervention

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
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	Muhimbili University of Health and Allied Sciences

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal loss, low birth weight and pre-term birth.		Delivery	No
Secondary	Child morbidity and mortality; child growth		12 months postpartum	No