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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00197548
Other study ID # HD37701
Secondary ID
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


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
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