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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,867
Blantyre District
Blantyre, Malawi
Chikwawa District
Chikwawa, Malawi
Proportion recovered from moderate acute malnutrition (MAM)
proportion of women who reach mid-upper arm circumference (MUAC) \> 23.5 cm for 2 consecutive visits
Time frame: up to 40 weeks
Maternal change in mid-upper arm circumference (MUAC)
average change in mid-upper-arm circumference
Time frame: up to 40 weeks
infant birth weight
mean birth weights of infants born to mothers in the study
Time frame: up to 40 weeks
infant birth length
mean birth length of infants born to women in the study
Time frame: up to 40 weeks
premature delivery
proportion of infants born prematurely
Time frame: up to 36 weeks
maternal weight gain
Time frame: up to 40 weeks
maternal hemoglobin
changes in average hemoglobin level
Time frame: 8 weeks
pregnancy complications
rate of pregnancy complications
Time frame: up to 40 weeks
infant weight at 3 months
Time frame: 3 months
infant length at 3 months
Time frame: 3 months
infant survival at 3 months
Time frame: 3 months
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