Back to resultsThe Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 1-3 Year Olds
Primary Purpose
Environmental Enteropathy
Status
Completed
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
cowpeas complementary food
corn-soy flour
common bean complementary food
Sponsored by
About this trial
This is an interventional treatment trial for Environmental Enteropathy
Eligibility Criteria
Inclusion Criteria:
- children residing in catchment area of Limela, Machinga District and N tenda (Chikwawa District), Malawi
- aged 12-35 months
- youngest eligible child in each household
Exclusion Criteria:Unable to drink 20 mL of sugar water
- Demonstrating evidence of severe acute malnutrition, WHZ < or = -3, presence of bi-pedal pitting edema
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Cowpeas
Common bean
Corn Soy Flour
Arm Description
Cowpea supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
Common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
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.
Outcomes
Primary Outcome Measures
Dual Sugar Absorption Test
lactulose-mannitol ratio in urine
Dual Sugar Absorption Test
lactulose-mannitol ratio in urine
Dual Sugar Absorption Test
lactulose-mannitol ratio in urine
Secondary Outcome Measures
Lactulose Excretion
percentage of ingested lactulose excreted in urine
Lactulose Excretion
percentage of ingested lactulose excreted in urine
Lactulose Excretion
percentage of ingested lactulose excreted in urine
Mannitol Excretion
percentage of ingested mannitol excreted in urine
Mannitol Excretion
percentage of ingested mannitol excreted in urine
Mannitol Excretion
percentage of ingested mannitol excreted in urine
Full Information
NCT ID
NCT02472301
First Posted
June 9, 2015
Last Updated
May 10, 2017
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02472301
Brief Title
The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 1-3 Year Olds
Official Title
Randomized, Single-blinded, Prospective Clinical Trial Comparing the Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction and Stunting in Rural Malawian Children 1-3 Year Olds
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine if 12 months of legume-based complementary foods is effective in reducing or reversing EED and linear growth faltering in a cohort of Malawian children, aged 12-35 months to see if these improvements are correlated with specific changes in the enteric microbiome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Environmental Enteropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
337 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cowpeas
Arm Type
Experimental
Arm Description
Cowpea supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
Arm Title
Common bean
Arm Type
Experimental
Arm Description
Common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
Arm Title
Corn Soy Flour
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
cowpeas complementary food
Intervention Description
cowpeas supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
corn-soy flour
Intervention Description
Corn-soy flour supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
common bean complementary food
Intervention Description
common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
Primary Outcome Measure Information:
Title
Dual Sugar Absorption Test
Description
lactulose-mannitol ratio in urine
Time Frame
3 months
Title
Dual Sugar Absorption Test
Description
lactulose-mannitol ratio in urine
Time Frame
6 months
Title
Dual Sugar Absorption Test
Description
lactulose-mannitol ratio in urine
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Lactulose Excretion
Description
percentage of ingested lactulose excreted in urine
Time Frame
3 months
Title
Lactulose Excretion
Description
percentage of ingested lactulose excreted in urine
Time Frame
6 months
Title
Lactulose Excretion
Description
percentage of ingested lactulose excreted in urine
Time Frame
12 months
Title
Mannitol Excretion
Description
percentage of ingested mannitol excreted in urine
Time Frame
3 months
Title
Mannitol Excretion
Description
percentage of ingested mannitol excreted in urine
Time Frame
6 months
Title
Mannitol Excretion
Description
percentage of ingested mannitol excreted in urine
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
35 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
children residing in catchment area of Limela, Machinga District and N tenda (Chikwawa District), Malawi
aged 12-35 months
youngest eligible child in each household
Exclusion Criteria:Unable to drink 20 mL of sugar water
Demonstrating evidence of severe acute malnutrition, WHZ < or = -3, presence of bi-pedal pitting edema
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Manary, MD
Organizational Affiliation
Washington University School of Medince
Official's Role
Principal Investigator
Facility Information:
City
Blantyre
Country
Malawi
12. IPD Sharing Statement
Citations:
PubMed Identifier
31022095
Citation
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.
Results Reference
derived
PubMed Identifier
29955682
Citation
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.
Results Reference
derived
PubMed Identifier
29490090
Citation
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.
Results Reference
derived
PubMed Identifier
26578308
Citation
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.
Results Reference
derived
Learn more about this trial
The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 1-3 Year Olds
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