MedDataX Logo

A Trial of Micronutrients and Adverse Pregnancy Outcomes

NCT ID: NCT00197548

Last Updated: 2010-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

8468 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2006-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Premature Birth Infant, Low Birth Weight Pregnancy Outcomes

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Women Pregnancy Outcomes Nutrition Vitamins Tanzania Maternal and Child Health Outcomes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Multivitamins

Multivitamins-vitamins B-complex, C, and E

Group Type ACTIVE_COMPARATOR

Multivitamins-vitamins B-complex, C, and E

Intervention Type DIETARY_SUPPLEMENT

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

Placebo pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* HIV negative
* 12-26 weeks gestational age at screening visit
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Muhimbili University of Health and Allied Sciences

OTHER

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Harvard School of Public of Health

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wafaie W Fawzi, MD,DrPh

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1056/NEJMoa064868.

Reference Type RESULT
PMID: 17409323 (View on PubMed)

Wang D, Shahab-Ferdows S, Lweno ON, Hampel D, Method B, Yelverton CA, Nguyen CH, Aboud S, Allen LH, Fawzi WW. The effects of prenatal and postnatal high-dose vitamin B-12 supplementation on human milk vitamin B-12: a randomized, double-blind, placebo-controlled trial in Tanzania. Am J Clin Nutr. 2024 Mar;119(3):730-739. doi: 10.1016/j.ajcnut.2023.07.023. Epub 2023 Nov 30.

Reference Type DERIVED
PMID: 38432714 (View on PubMed)

Cliffer I, Darling AM, Madzorera I, Wang D, Perumal N, Wang M, Liu E, Pembe AB, Urassa W, Fawzi WW. Associations of Diet Quality, Socioeconomic Factors, and Nutritional Status with Gestational Weight Gain among Pregnant Women in Dar es Salaam, Tanzania. Curr Dev Nutr. 2023 Feb 4;7(3):100041. doi: 10.1016/j.cdnut.2023.100041. eCollection 2023 Mar.

Reference Type DERIVED
PMID: 37181931 (View on PubMed)

Kamenju P, Madzorera I, Hertzmark E, Urassa W, Fawzi WW. Higher Dietary Intake of Animal Protein Foods in Pregnancy Is Associated with Lower Risk of Adverse Birth Outcomes. J Nutr. 2022 Nov;152(11):2546-2554. doi: 10.1093/jn/nxac183. Epub 2022 Aug 18.

Reference Type DERIVED
PMID: 36774120 (View on PubMed)

Liu E, Wang D, Darling AM, Perumal N, Wang M, Urassa W, Pembe A, Fawzi WW. Multivitamin Supplementation Is Associated with Greater Adequacy of Gestational Weight Gain among Pregnant Women in Tanzania. J Nutr. 2022 Apr 1;152(4):1091-1098. doi: 10.1093/jn/nxab448.

Reference Type DERIVED
PMID: 34964890 (View on PubMed)

Wang D, Natchu UCM, Darling AM, Noor RA, Hertzmark E, Urassa W, Fawzi WW. Effects of prenatal and postnatal maternal multiple micronutrient supplementation on child growth and morbidity in Tanzania: a double-blind, randomized-controlled trial. Int J Epidemiol. 2022 Dec 13;51(6):1761-1774. doi: 10.1093/ije/dyab117.

Reference Type DERIVED
PMID: 34151973 (View on PubMed)

Madzorera I, Isanaka S, Wang M, Msamanga GI, Urassa W, Hertzmark E, Duggan C, Fawzi WW. Maternal dietary diversity and dietary quality scores in relation to adverse birth outcomes in Tanzanian women. Am J Clin Nutr. 2020 Sep 1;112(3):695-706. doi: 10.1093/ajcn/nqaa172.

Reference Type DERIVED
PMID: 32651998 (View on PubMed)

Quinn MK, Smith ER, Williams PL, Urassa W, Shi J, Msamanga G, Fawzi WW, Sudfeld CR. The Effect of Maternal Multiple Micronutrient Supplementation on Female Early Infant Mortality Is Fully Mediated by Increased Gestation Duration and Intrauterine Growth. J Nutr. 2020 Feb 1;150(2):356-363. doi: 10.1093/jn/nxz246.

Reference Type DERIVED
PMID: 31605616 (View on PubMed)

Winje BA, Kvestad I, Krishnamachari S, Manji K, Taneja S, Bellinger DC, Bhandari N, Bisht S, Darling AM, Duggan CP, Fawzi W, Hysing M, Kumar T, Kurpad AV, Sudfeld CR, Svensen E, Thomas S, Strand TA. Does early vitamin B12 supplementation improve neurodevelopment and cognitive function in childhood and into school age: a study protocol for extended follow-ups from randomised controlled trials in India and Tanzania. BMJ Open. 2018 Feb 22;8(2):e018962. doi: 10.1136/bmjopen-2017-018962.

Reference Type DERIVED
PMID: 29472265 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HD37701

Identifier Type: -

Identifier Source: org_study_id