The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 1-3 Year Olds

Sponsor

Washington University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT02472301

Collaborator

(none)

337

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Environmental Enteropathy	Dietary Supplement: cowpeas complementary food Dietary Supplement: corn-soy flour Dietary Supplement: common bean complementary food	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

337 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cowpeas Cowpea supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.	Dietary Supplement: 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.
Experimental: 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.	Dietary Supplement: 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.
Active Comparator: 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.	Dietary Supplement: 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.

Arm

Intervention/Treatment

Experimental: Cowpeas

Cowpea supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.

Dietary Supplement: 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.

Experimental: 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.

Dietary Supplement: 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.

Active Comparator: 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.

Dietary Supplement: 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.

Outcome Measures

Primary Outcome Measures

Dual Sugar Absorption Test [3 months]
lactulose-mannitol ratio in urine
Dual Sugar Absorption Test [6 months]
lactulose-mannitol ratio in urine
Dual Sugar Absorption Test [12 months]
lactulose-mannitol ratio in urine

Secondary Outcome Measures

Lactulose Excretion [3 months]
percentage of ingested lactulose excreted in urine
Lactulose Excretion [6 months]
percentage of ingested lactulose excreted in urine
Lactulose Excretion [12 months]
percentage of ingested lactulose excreted in urine
Mannitol Excretion [3 months]
percentage of ingested mannitol excreted in urine
Mannitol Excretion [6 months]
percentage of ingested mannitol excreted in urine
Mannitol Excretion [12 months]
percentage of ingested mannitol excreted in urine

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Months to 35 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Blantyre		Malawi

Sponsors and Collaborators

Washington University School of Medicine

Investigators

Principal Investigator: Mark Manary, MD, Washington University School of Medince

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT02472301

Other Study ID Numbers:

First Posted:

Jun 15, 2015

Last Update Posted:

May 11, 2017

Last Verified:

May 1, 2017

Additional relevant MeSH terms:

Intestinal Diseases

Study Results

No Results Posted as of May 11, 2017