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Trial record 33 of 110 for:    test | ( Map: Malawi )

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

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ClinicalTrials.gov Identifier: NCT02472301
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : August 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

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.




Primary Outcome Measures :
  1. Dual Sugar Absorption Test [ Time Frame: 3 months ]
    lactulose-mannitol ratio in urine

  2. Dual Sugar Absorption Test [ Time Frame: 6 months ]
    lactulose-mannitol ratio in urine

  3. Dual Sugar Absorption Test [ Time Frame: 12 months ]
    lactulose-mannitol ratio in urine


Secondary Outcome Measures :
  1. Lactulose Excretion [ Time Frame: 3 months ]
    percentage of ingested lactulose excreted in urine

  2. Lactulose Excretion [ Time Frame: 6 months ]
    percentage of ingested lactulose excreted in urine

  3. Lactulose Excretion [ Time Frame: 12 months ]
    percentage of ingested lactulose excreted in urine

  4. Mannitol Excretion [ Time Frame: 3 months ]
    percentage of ingested mannitol excreted in urine

  5. Mannitol Excretion [ Time Frame: 6 months ]
    percentage of ingested mannitol excreted in urine

  6. Mannitol Excretion [ Time Frame: 12 months ]
    percentage of ingested mannitol excreted in urine



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Ages Eligible for Study:   12 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02472301


Locations
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Malawi
Blantyre, Malawi
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Mark Manary, MD Washington University School of Medince