NCT02472301

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
337

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 11, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

June 9, 2015

Last Update Submit

May 10, 2017

Conditions

Environmental Enteropathy

Outcome Measures

Primary Outcomes (3)

  • Dual Sugar Absorption Test

    lactulose-mannitol ratio in urine

    3 months

  • Dual Sugar Absorption Test

    lactulose-mannitol ratio in urine

    6 months

  • Dual Sugar Absorption Test

    lactulose-mannitol ratio in urine

    12 months

Secondary Outcomes (6)

  • Lactulose Excretion

    3 months

  • Lactulose Excretion

    6 months

  • Lactulose Excretion

    12 months

  • Mannitol Excretion

    3 months

  • Mannitol Excretion

    6 months

  • +1 more secondary outcomes

Study Arms (3)

Cowpeas

EXPERIMENTAL

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

Common bean

EXPERIMENTAL

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

Corn Soy Flour

ACTIVE COMPARATOR

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

Interventions

cowpeas complementary foodDIETARY_SUPPLEMENT

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

Cowpeas
corn-soy flourDIETARY_SUPPLEMENT

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

Corn Soy Flour
common bean complementary foodDIETARY_SUPPLEMENT

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

Eligibility Criteria

Age12 Months - 35 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Blantyre, Malawi

Location

Related Publications (4)

  • 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.

    PMID: 31022095DERIVED

  • 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.

    PMID: 29955682DERIVED

  • 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.

    PMID: 29490090DERIVED

  • 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.

    PMID: 26578308DERIVED

Study Officials

  • Mark Manary, MD

    Washington University School of Medince

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2015

First Posted

June 15, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 11, 2017

Record last verified: 2017-05

Locations

MA(1)