Combined Package of Interventions for Environmental Enteropathy
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Multiple Intervention Arm single dose albendazole, two weeks of zinc, 24 weeks of multiple micronutrients |
Drug: Albendazole
Dietary Supplement: Zinc
Dietary Supplement: Multiple Micronutrient Supplement
|
Placebo Comparator: Placebo three placebos |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Dual Sugar Absorption Test [12 weeks]
lactulose-mannitol ratio in urine
- Dual Sugar Absorption Test [24 weeks]
lactulose-mannitol ratio in urine
Secondary Outcome Measures
- Lactulose Excretion [12 weeks]
percentage of ingested lactulose excreted in urine
- Lactulose Excretion [24 weeks]
percentage of ingested lactulose excreted in urine
- Mannitol Excretion [12 weeks]
percentage of ingested mannitol excreted in urine
- Mannitol Excretion [24 weeks]
percentage of ingested mannitol excreted in urine
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Limela Rural Site | Limela | Machinga Distric | Malawi |
Sponsors and Collaborators
- Washington University School of Medicine
- University of Malawi
Investigators
- Principal Investigator: Mark J Manary, MD, Washington University in St. Louis; University of Malawi
- Study Director: Chrissie Thakwalakwa, PhD, University of Malawi
- Study Director: Indi Trehan, MD MPH DTM&H, Washington University in St. Louis; University of Malawi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EE-zinc-alb-micronut