Randomized, Double-blind, Placebo-controlled Trial Evaluating the Impact of High-dose Zinc Therapy and Albendazole in the Treatment of Sub-clinical Environmental Enteropathy in Rural Malawian Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 225
- Locations
- 1
- Primary Endpoint
- Changes in urine lactulose:mannitol (L:M) ratio following therapy course.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Year to 3 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Zinc therapy
High-dose zinc, equivalent 20 mg elemental zinc, to be given once per day for 14 days
Intervention: High-dose Zinc (Dietary Supplement)
Albendazole
Albendazole to be given once on the day of enrollment. Placebo will then be given for 13 days following.
Intervention: Albendazole (Drug)
Placebo
Placebo will be given for 14 days
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Changes in urine lactulose:mannitol (L:M) ratio following therapy course.
Time Frame: 4 weeks, 7 weeks
Secondary Outcomes
- Change in blood endoCAb(7 weeks)
- Change in fecal calprotectin mRNA(4 weeks, 7 weeks)