Interventions for Moderate Malnutrition in Pregnancy

Study Overview
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Brief Summary
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Malnutrition during pregnancy is more common in poor women in the developing world due to inadequate dietary intake combined with increased nutrient requirements; pregnancy risk is more consequential than among other demographic groups with increased risk of maternal and infant mortality and the lifelong effects of fetal malnutrition. The benefits of treating moderate malnutrition during pregnancy remain largely undocumented. This study tests the hypothesis that providing either a fortified flour or fortified paste-based supplementary food designed to replete the nutrient deficits during pregnancy will result in improved maternal nutritional recovery rates and higher infant birth weights and lengths. This study is a randomized, controlled clinical trial of 3 supplementary foods in 1800 moderately malnourished Malawian women who are pregnant. Subjects will receive one of 3 food rations: 1) a ready-to-use supplementary food formulated to deliver about 200% of the recommended daily allowance (RDA) of most micronutrients in pregnancy (RUSF-P), 2) corn soy blend with a multiple micronutrient tablet chosen to deliver about 200% of the RDA of most micronutrients (CSB-P) or 3), the standard of care which is a corn soy blend with supplementary iron and folic acid (CSB), delivering between 0-350% of the RDA. Subjects will receive the supplementary food until they recover from MAM. The outcome of the pregnancy and maternal nutritional status will be followed until 3 months after delivery.

Official Title
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Randomized Controlled Trial of the Impact of Treating Moderately Malnourished Women in Pregnancy

Conditions
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Pregnancy, Moderate Malnutrition

Intervention / Treatment
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* Dietary Supplement: ready-to-use supplementary food
* Dietary Supplement: corn-soy blend
* Dietary Supplement: iron
* Dietary Supplement: folic acid
* Dietary Supplement: UNIMMAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant and consenting to study participation and HIV testing (if not already performed) mid-upper-arm circumference (MUAC) ≤ 23 cm planning to stay in the area and attend the clinic during pregnancy and for 3 months post partum Exclusion Criteria: Pregnancy complications such as gestational diabetes, pre-eclampsia, hypertension Severe anemia (Hg <7.0 mg/dl) Severe malnutrition under 18 years of age over estimated 35 weeks of gestation

Ages Eligible for Study
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Minimum Age: 14 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: corn-soy-blend<br>This is the control group for the study, which will receive the Malawi standard of care. The treatment provided to women randomized to this arm of the study includes daily iron (60 mg) and folic acid (400 mcg) supplementation, along with 4 kg/2 weeks corn-soy blend ( 357 gm/d CSB). | Dietary Supplement: corn-soy blend<br> <br> Dietary Supplement: iron<br> <br> Dietary Supplement: folic acid<br> <br> |
| Experimental: corn-soy-blend + multiple micronutrients<br>The treatment provided to women randomized to this arm of the study includes 200gm/d CSB along with a standard maternal multiple micronutrient tablet, which together provide a comparable amount of energy, protein and micronutrients to the ready-to-use supplemental food. The micronutrient supplement known as the United Nations Children's Emergency Fund (UNICEF) / World Health Organization (WHO) / United Nations University (UNU) international multiple micronutrient preparation (UNIMMAP) is widely available and has been used in many settings worldwide in pregnant women. | Dietary Supplement: corn-soy blend<br> <br> Dietary Supplement: UNIMMAP<br> <br> |
| Experimental: ready-to-use supplementary food<br>RUSF-P (ready-to-use supplementary food) provides 750 kcal/d, 20 g protein/d, and 200% of RDA/d for most micronutrients during pregnancy (except for vitamins A, B3, folic acid, minerals iodine, magnesium, and calcium which will remain near 100%) | Dietary Supplement: ready-to-use supplementary food<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion recovered from moderate acute malnutrition (MAM) | proportion of women who reach mid-upper arm circumference (MUAC) > 23.5 cm for 2 consecutive visits | up to 40 weeks | 
| Maternal change in mid-upper arm circumference (MUAC) | average change in mid-upper-arm circumference | up to 40 weeks | 
| infant birth weight | mean birth weights of infants born to mothers in the study | up to 40 weeks | 
| infant birth length | mean birth length of infants born to women in the study | up to 40 weeks | 
| premature delivery | proportion of infants born prematurely | up to 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal weight gain |  | up to 40 weeks | 
| maternal hemoglobin | changes in average hemoglobin level | 8 weeks | 
| pregnancy complications | rate of pregnancy complications | up to 40 weeks | 
| infant weight at 3 months |  | 3 months | 
| infant length at 3 months |  | 3 months | 
| infant survival at 3 months |  | 3 months |