A Trial of Micronutrients and Adverse Pregnancy Outcomes

Conditions

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

Keywords

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

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.

Wang D, Shahab-Ferdows S, Lweno ON, Hampel D, Method B, Yelverton CA, Nguyen CH, Aboud S, Allen LH, Fawzi WW.

2023-11-301 citations

10.1016/j.ajcnut.2023.07.023

Associations of Diet Quality, Socioeconomic Factors, and Nutritional Status with Gestational Weight Gain among Pregnant Women in Dar es Salaam, Tanzania.

Cliffer I, Darling AM, Madzorera I, Wang D, Perumal N, Wang M, Liu E, Pembe AB, Urassa W, Fawzi WW.

2023-02-047 citations

10.1016/j.cdnut.2023.100041

Multivitamin Supplementation Is Associated with Greater Adequacy of Gestational Weight Gain among Pregnant Women in Tanzania.

Liu E, Wang D, Darling AM, Perumal N, Wang M, Urassa W, Pembe A, Fawzi WW.

2022-04-018 citations

10.1093/jn/nxab448

Maternal dietary diversity and dietary quality scores in relation to adverse birth outcomes in Tanzanian women.

Madzorera I, Isanaka S, Wang M, Msamanga GI, Urassa W, Hertzmark E, Duggan C, Fawzi WW.

2020-09-0157 citations

10.1093/ajcn/nqaa172

Vitamin B12 is Low in Milk of Early Postpartum Women in Urban Tanzania, and was not Significantly Increased by High dose Supplementation

Omar Lweno, Christopher R. Sudfeld, Ellen Hertzmark, Karim Manji, Said Aboud et al. (11 authors)

Nutrients2020-03-3112 citations

10.3390/nu12040963

The Effect of Maternal Multiple Micronutrient Supplementation on Female Early Infant Mortality Is Fully Mediated by Increased Gestation Duration and Intrauterine Growth.

Quinn MK, Smith ER, Williams PL, Urassa W, Shi J, Msamanga G, Fawzi WW, Sudfeld CR.

2020-02-015 citations

10.1093/jn/nxz246

Does early vitamin B<sub>12</sub> 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

Brita Askeland Winje, Ingrid Kvestad, Krishnamachari Srinivasan, Karim Manji, Sunita Taneja et al. (18 authors)

BMJ Open2018-02-0138 citations

10.1136/bmjopen-2017-018962

Vitamins and perinatal outcomes among HIV-negative women in Tanzania.

Fawzi WW, Msamanga GI, Urassa W, Hertzmark E, Petraro P, Willett WC, Spiegelman D.

2007-04-01141 citations

10.1056/nejmoa064868

Interventions

DIETARY_SUPPLEMENTMultivitamins-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.

DIETARY_SUPPLEMENTPlacebo

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Fetal loss, low birth weight and pre-term birth.	Delivery

Secondary

Measure	Time frame
Child morbidity and mortality; child growth	12 months postpartum

Outcome results

None listed