Randomized Controlled Trial of the Impact of Treating Moderately Malnourished Women in Pregnancy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,867
- Locations
- 2
- Primary Endpoint
- Maternal change in mid-upper arm circumference (MUAC)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 14 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
corn-soy-blend
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).
Intervention: corn-soy blend (Dietary Supplement)
corn-soy-blend + multiple micronutrients
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.
Intervention: corn-soy blend (Dietary Supplement)
corn-soy-blend + multiple micronutrients
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.
Intervention: UNIMMAP (Dietary Supplement)
ready-to-use supplementary food
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%)
Intervention: ready-to-use supplementary food (Dietary Supplement)
corn-soy-blend
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).
Intervention: folic acid (Dietary Supplement)
corn-soy-blend
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).
Intervention: iron (Dietary Supplement)
Outcomes
Primary Outcomes
Maternal change in mid-upper arm circumference (MUAC)
Time Frame: up to 40 weeks
average change in mid-upper-arm circumference
infant birth weight
Time Frame: up to 40 weeks
mean birth weights of infants born to mothers in the study
Proportion recovered from moderate acute malnutrition (MAM)
Time Frame: up to 40 weeks
proportion of women who reach mid-upper arm circumference (MUAC) \> 23.5 cm for 2 consecutive visits
premature delivery
Time Frame: up to 36 weeks
proportion of infants born prematurely
infant birth length
Time Frame: up to 40 weeks
mean birth length of infants born to women in the study
Secondary Outcomes
- pregnancy complications(up to 40 weeks)
- maternal weight gain(up to 40 weeks)
- infant length at 3 months(3 months)
- maternal hemoglobin(8 weeks)
- infant survival at 3 months(3 months)
- infant weight at 3 months(3 months)