The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 1-3 Year Olds
NCT ID: NCT02472301
Last Updated: 2017-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
337 participants
INTERVENTIONAL
2015-08-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cowpeas
Cowpea supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
cowpeas complementary food
cowpeas supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
Common bean
Common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
common bean complementary food
common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
Corn Soy Flour
Corn flour with 10% soy supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
corn-soy flour
Corn-soy flour supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
Interventions
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cowpeas complementary food
cowpeas supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
corn-soy flour
Corn-soy flour supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
common bean complementary food
common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
Eligibility Criteria
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Inclusion Criteria
* aged 12-35 months
* youngest eligible child in each household
Exclusion Criteria
* Apparent need for acute medical treatment for an illness or injury
* Caregiver refusal to participate and return for 3, 6 and 12 month follow-ups
12 Months
35 Months
ALL
Yes
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Mark Manary, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medince
Locations
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Blantyre, , Malawi
Countries
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References
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Kaimila Y, Pitman RT, Divala O, Hendrixson DT, Stephenson KB, Agapova S, Trehan I, Maleta K, Manary MJ. Development of Acute Malnutrition Despite Nutritional Supplementation in Malawi. J Pediatr Gastroenterol Nutr. 2019 May;68(5):734-737. doi: 10.1097/MPG.0000000000002241.
Borresen EC, Zhang L, Trehan I, Nealon NJ, Maleta KM, Manary MJ, Ryan EP. The Nutrient and Metabolite Profile of 3 Complementary Legume Foods with Potential to Improve Gut Health in Rural Malawian Children. Curr Dev Nutr. 2017 Sep 21;1(10):e001610. doi: 10.3945/cdn.117.001610. eCollection 2017 Oct.
Agapova SE, Stephenson KB, Divala O, Kaimila Y, Maleta KM, Thakwalakwa C, Ordiz MI, Trehan I, Manary MJ. Additional Common Bean in the Diet of Malawian Children Does Not Affect Linear Growth, but Reduces Intestinal Permeability. J Nutr. 2018 Feb 1;148(2):267-274. doi: 10.1093/jn/nxx013.
Trehan I, Benzoni NS, Wang AZ, Bollinger LB, Ngoma TN, Chimimba UK, Stephenson KB, Agapova SE, Maleta KM, Manary MJ. Common beans and cowpeas as complementary foods to reduce environmental enteric dysfunction and stunting in Malawian children: study protocol for two randomized controlled trials. Trials. 2015 Nov 14;16:520. doi: 10.1186/s13063-015-1027-0.
Other Identifiers
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LG2
Identifier Type: -
Identifier Source: org_study_id
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