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

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT01440608
• Collaborator: (none)
• Enrollment: 225
• Location: 1
• Arms: 3
• Duration (Months): 2
• Patients Per Site Per Month: 112.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Enteropathy	Drug: Albendazole; Drug: Placebo; Dietary Supplement: High-dose Zinc	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 225 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zinc therapy High-dose zinc, equivalent 20 mg elemental zinc, to be given once per day for 14 days	Dietary Supplement: High-dose Zinc; Pill form, equivalent to 20 mg elemental zinc, to be given once per day for 14 days
Experimental: Albendazole Albendazole to be given once on the day of enrollment. Placebo will then be given for 13 days following.	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 Comparator: Placebo Placebo will be given for 14 days	Drug: 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.

Outcome Measures

Primary Outcome Measures

1. Changes in urine lactulose:mannitol (L:M) ratio following therapy course. [4 weeks, 7 weeks]

Secondary Outcome Measures

1. Change in blood endoCAb [7 weeks]

2. Change in fecal calprotectin mRNA [4 weeks, 7 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 3 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint Louis Nutrition Project	Blantyre		Malawi

Sponsors and Collaborators

• Washington University School of Medicine

Investigators

• Principal Investigator: Mark J Manary, MD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT01440608
• Other Study ID Numbers: MJM-zincalbendazole
• First Posted: Sep 26, 2011
• Last Update Posted: Mar 6, 2012
• Last Verified: Mar 1, 2012

• Additional relevant MeSH terms: Intestinal Diseases; Albendazole

Study Results

No Results Posted as of Mar 6, 2012