A Trial of Micronutrients and Adverse Pregnancy Outcomes

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Trial of Micronutrients and Adverse Pregnancy Outcomes

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

Intervention / Treatment
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* Dietary Supplement: Multivitamins-vitamins B-complex, C, and E
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV negative 12-26 weeks gestational age at screening visit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Multivitamins<br>Multivitamins-vitamins B-complex, C, and E | Dietary Supplement: Multivitamins-vitamins B-complex, C, and E<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Placebo pill | Dietary Supplement: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal loss, low birth weight and pre-term birth. |  | Delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child morbidity and mortality; child growth |  | 12 months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Women, Pregnancy Outcomes, Nutrition, Vitamins, Tanzania, Maternal and Child Health Outcomes