Effectiveness of High-dose Zinc Therapy and Albendazole in the Treatment of Environmental Enteropathy

Enteropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440608
• Other study ID #: MJM-zincalbendazole
• Status: Completed
• Phase: N/A
• First received: September 22, 2011
• Last updated: March 2, 2012
• Start date: October 2011
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardMalawi: College of Medicine Research and Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 3 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enteropathy
• Intestinal Diseases

Intervention

Drug:
• Albendazole
Pill form, to be given once, 200 mg dosage for children 1-2 years of age, 400 mg dosage for children 2-3 years of age
• Placebo
Pill form, 400 mg dose to be given once per day for 14 days in Placebo arm and 13 days in Albendazole arm following one dose of Albendazole.

Dietary Supplement:
• High-dose Zinc
Pill form, equivalent to 20 mg elemental zinc, to be given once per day for 14 days

Locations

Country	Name	City	State
Malawi	Saint Louis Nutrition Project	Blantyre

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in urine lactulose:mannitol (L:M) ratio following therapy course.		4 weeks, 7 weeks	No
Secondary	Change in blood endoCAb		7 weeks	No
Secondary	Change in fecal calprotectin mRNA		4 weeks, 7 weeks	No