A Trial of Micronutrients and Adverse Pregnancy Outcomes

NCT00197548 | Completed Phase 3 DMC

• 1 other identifier: HD37701
• Study Type: interventional
• Target: 8,468
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Women; Pregnancy Outcomes; Nutrition; Vitamins; Tanzania; Maternal and Child Health Outcomes

Outcome Measures

Primary Outcomes (1)

• Fetal loss, low birth weight and pre-term birth.

  Delivery

Secondary Outcomes (1)

• Child morbidity and mortality; child growth

  12 months postpartum

Study Arms (2)

Multivitamins

ACTIVE COMPARATOR

Multivitamins-vitamins B-complex, C, and E

Dietary Supplement: Multivitamins-vitamins B-complex, C, and E

Placebo

PLACEBO COMPARATOR

Placebo pill

Dietary Supplement: Placebo

Interventions

Multivitamins-vitamins B-complex, C, and E 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.

Multivitamins

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV negative
• weeks gestational age at screening visit

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Muhimbili University of Health and Allied Sciences: collaborator

Related Publications (9)

• 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.

  PMID: 17409323 RESULT

• 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.

  PMID: 38432714 DERIVED

• 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.

  PMID: 37181931 DERIVED

• 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.

  PMID: 36774120 DERIVED

• 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.

  PMID: 34964890 DERIVED

• 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.

  PMID: 34151973 DERIVED

• 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.

  PMID: 32651998 DERIVED

• 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.

  PMID: 31605616 DERIVED

• 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.

  PMID: 29472265 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Wafaie W Fawzi, MD,DrPh

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: August 1, 2001
• Primary Completion: December 1, 2004
• Study Completion: July 1, 2006
• Last Updated: November 11, 2010

Record last verified: 2010-11