An interventional study of Ready-to-use-supplementary food and Corn-soy-blend in Pregnancy, Malnutrition in Pregnancy and Nutrition Disorders, sponsored by Washington University School of Medicine. Completed at 1 site in Sierra Leone. Open to female participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2021-01-07.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
Acute malnutrition in pregnancy is a risk factor for adverse outcomes in mothers and their unborn children. Undernutrition during pregnancy can result in maternal complications such as life-threatening hemorrhage and hypertensive disorders of pregnancy and infant complications such as intrauterine growth retardation, low birth weight, pre-term delivery and poor cognitive development. Poor women in the developing world are at heightened risk of malnutrition due to inadequate dietary intake and are subject to transmission of a number of infections including malaria, intestinal helminths, and genitourinary infections. Food interventions for malnutrition may be less effective under conditions with excessive inflammation and infection, and especially so during pregnancy. Without specifically addressing treatment for infections, undernourished mothers may be less responsive to nutritional interventions. The benefits of treating both malnutrition and common infections simultaneously remain largely unstudied. This study tests the hypothesis that malnourished pregnant women receiving 100 grams per day of a specially formulated ready-to-use supplementary food in addition to a combination of 5 anti-infective interventions will have greater weight gain in pregnancy and deliver larger, longer infants than women receiving the standard of care. The outcome of the pregnancy and maternal nutritional status will be followed until 6 months after delivery.
233 studies on the registry are indexed under Nutrition Disorders; 26 are open to participants now.
This study's enrollment of 1,489 is above the median of 105 across 169 interventional studies indexed under Nutrition Disorders.
Browse Nutrition Disorders studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
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The women randomized to this arm will receive a ready-to-use-supplementary food (RUSF) designed specifically for pregnancy. The RUSF will provide a total of 520 kcal, 18 g protein, and 200% of recommended daily allowance (RDA) for most micronutrients during pregnancy. The supplement is also optimized to provide excellent protein quality and optimal polyunsaturated fatty acid composition. These women will receive 5 anti-infective interventions: 1) insecticide-treated mosquito net, 2) monthly intermittent preventive treatment of malaria during pregnancy (IPTp) 3) azithromycin at the second and third trimester 4) albendazole given in second trimester, and 5) bacterial vaginosis testing and treatment at enrollment and again at weeks 28-34
Dietary Supplement: Ready-to-use-supplementary food · Drug: Monthly intermittent preventive treatment of malaria during pregnancy (IPTp) · Other: Insecticide-treated mosquito net · Drug: Azithromycin · Drug: Albendazole · Combination Product: Bacterial vaginosis testing and treatment
The women randomized to this arm will receive the standard of care for Sierra Leone. The treatment provided to women in this group includes 3.5 kg super cereal with 350 g vegetable oil every two weeks. This provides 250 mg portion/day of the super cereal and 25g oil/day for the mother. Women will receive the food for the duration of their pregnancy. These women will receive the current recommendations of the government of Sierra Leone, which includes standard intermittent preventive treatment of malaria during pregnancy (IPTp) of 2 doses of sulfadoxine/ pyrimethamine, iron and folic acid supplement with a goal of 90 pills/pregnancy, an insecticide-treated mosquito net, and albendazole for deworming in the second trimester.
Dietary Supplement: Corn-soy-blend · Drug: Standard intermittent preventive treatment of malaria during pregnancy (IPTp) · Other: Insecticide-treated mosquito net · Drug: Albendazole
Specially formulated supplementary food for pregnancy
Standard of care for malnutrition in pregnancy in Sierra Leone
Sulfadoxine-pyrimethamine (500 mg / 25 mg) given every 4 weeks, beginning at enrollment or at 13 weeks' gestation, whichever is later.
Also known as: Sulfadoxine-pyrimethamine
Standard of care for Sierra Leone is 2 doses of sulfadoxine/ pyrimethamine (500mg/ 25mg).
Also known as: Sulfadoxine-pyrimethamine
An insecticide-treated mosquito net at the time of enrollment into the study.
Azithromycin 1 gram given once in second trimester and again during weeks 28-34 of gestation.
Single dose albendazole 400mg given in the second trimester.
Testing for bacterial vaginosis at enrollment and again at weeks 28-34 using a rapid diagnostic test for sialidase. Those with positive tests will receive extended release metronidazole 750mg daily for 7 days.
Infant birth length
mean birth length of infants born to mothers in the study
Time frame: up to 40 weeks
Maternal weight gain
Average weekly weight gain of women in the study
Time frame: up to 40 weeks
Proportion recovered from maternal malnutrition
proportion of women who reach mid-upper-arm circumference (MUAC) \> 23 cm
Time frame: up to 40 weeks
Premature delivery
proportion of infants born prematurely
Time frame: up to 36 weeks
Newborn head circumference
mean head circumference of infants born to women in the study
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 weight at 6 weeks, 3 and 6 months
infant ponderal growth
Time frame: up to 6 months
Infant length at 6 weeks, 3 and 6 months
infant linear growth
Time frame: up to 6 months
Infant survival at 3 and 6 months
survival of infants in the study
Time frame: up to 6 months
Ran from Feb 2017 to primary completion in Sep 2019, 30 months.
Of 54 non-industry interventional studies with no phase under Nutrition Disorders, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 57. This study's 30 months is above that.
Counting every sponsor, half of 56 studies reached it within 22 months; a quarter within 10 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Azithromycin
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