Clinical trial NCT00197548: A Trial of Micronutrients and Adverse Pregnancy Outcomes
Official title: A Trial of Micronutrients and Adverse Pregnancy Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pregnancy
Premature Birth
Infant, Low Birth Weight
Pregnancy Outcomes
Keywords: Women
Pregnancy Outcomes
Nutrition
Vitamins
Tanzania
Maternal and Child Health Outcomes
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Muhimbili University of Health and Allied Sciences
First posted: 2005-09-20
Enrollment: 8468
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Fetal loss, low birth weight and pre-term birth.
timeFrame: Delivery
Secondary outcomes:
measure: Child morbidity and mortality; child growth
timeFrame: 12 months postpartum
Other outcomes:
Locations:
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Wafaie W Fawzi, MD,DrPh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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 Aug 18;152(11):2546-54. doi: 10.1093/jn/nxac183. Online ahead of print.
citation: 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.
citation: 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.
citation: 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.
citation: 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.