Environmental Enteropathy
Conditions
Brief summary
Randomized, double-blind, placebo controlled trial of a combined intervention of zinc, albendazole, and multiple micronutrients in improving environmental enteropathy in Malawian children.
Interventions
Sponsors
University of Malawi
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 35 Months
Healthy volunteers
Yes
Inclusion criteria
* children residing in catchment area of Limela, Machinga District, Malawi * aged 12-35 months * youngest eligible child in each household
Exclusion criteria
* severe acute malnutrition * severe chronic illness * children unable to drink 20 mL of dual sugar solution * children in need of acute medical treatment for illness or injury at time of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dual Sugar Absorption Test | 12 weeks | lactulose-mannitol ratio in urine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lactulose Excretion | 12 weeks | percentage of ingested lactulose excreted in urine |
| Mannitol Excretion | 12 weeks | percentage of ingested mannitol excreted in urine |
Countries
Malawi
Outcome results
None listed