Moderate Malnutrition, Pregnancy
Conditions
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.
Interventions
DIETARY_SUPPLEMENTready-to-use supplementary food
DIETARY_SUPPLEMENTcorn-soy blend
DIETARY_SUPPLEMENTiron
DIETARY_SUPPLEMENTfolic acid
DIETARY_SUPPLEMENTUNIMMAP
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion recovered from moderate acute malnutrition (MAM) | up to 40 weeks | proportion of women who reach mid-upper arm circumference (MUAC) \> 23.5 cm for 2 consecutive visits |
| Maternal change in mid-upper arm circumference (MUAC) | up to 40 weeks | average change in mid-upper-arm circumference |
| infant birth weight | up to 40 weeks | mean birth weights of infants born to mothers in the study |
| infant birth length | up to 40 weeks | mean birth length of infants born to women in the study |
| premature delivery | up to 36 weeks | proportion of infants born prematurely |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| maternal weight gain | up to 40 weeks | — |
| infant survival at 3 months | 3 months | — |
| maternal hemoglobin | 8 weeks | changes in average hemoglobin level |
| pregnancy complications | up to 40 weeks | rate of pregnancy complications |
| infant weight at 3 months | 3 months | — |
| infant length at 3 months | 3 months | — |
Countries
Malawi
Outcome results
None listed