Effectiveness of High-dose Zinc Therapy and Albendazole in the Treatment of Environmental Enteropathy
Not Applicable
Completed
- Conditions
- Enteropathy
- Interventions
- Registration Number
- NCT01440608
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
The purpose of this study is to investigate the therapeutic effectiveness of high-dose zinc therapy and de-worming albendazole as separate interventions in restoring normal gut absorptive and immunological function as measured by the dual sugar permeability test and additional biomarkers in 1-3 year old rural Malawian children at high risk for Environmental Enteropathy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 225
Inclusion Criteria
- 1-3 years of age
- Lives in study villages
Exclusion Criteria
- Unable to drink 100 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
- Parent refusal to participate and return for 7-week follow-up
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Zinc therapy High-dose Zinc High-dose zinc, equivalent 20 mg elemental zinc, to be given once per day for 14 days Placebo Placebo Placebo will be given for 14 days Albendazole Albendazole Albendazole to be given once on the day of enrollment. Placebo will then be given for 13 days following.
- Primary Outcome Measures
Name Time Method Changes in urine lactulose:mannitol (L:M) ratio following therapy course. 4 weeks, 7 weeks
- Secondary Outcome Measures
Name Time Method Change in blood endoCAb 7 weeks Change in fecal calprotectin mRNA 4 weeks, 7 weeks
Trial Locations
- Locations (1)
Saint Louis Nutrition Project
🇲🇼Blantyre, Malawi