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

NCT01440608 | Completed

• 1 other identifier: MJM-zincalbendazole
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Enteropathy

Outcome Measures

Primary Outcomes (1)

• Changes in urine lactulose:mannitol (L:M) ratio following therapy course.

  4 weeks, 7 weeks

Secondary Outcomes (2)

• Change in blood endoCAb

  7 weeks

• Change in fecal calprotectin mRNA

  4 weeks, 7 weeks

Study Arms (3)

Zinc therapy

EXPERIMENTAL

High-dose zinc, equivalent 20 mg elemental zinc, to be given once per day for 14 days

Dietary Supplement: High-dose Zinc

Albendazole

EXPERIMENTAL

Albendazole to be given once on the day of enrollment. Placebo will then be given for 13 days following.

Drug: Albendazole

Placebo

PLACEBO COMPARATOR

Placebo will be given for 14 days

Drug: Placebo

Interventions

Albendazole DRUG

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

Albendazole

Placebo DRUG

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.

Placebo

High-dose Zinc DIETARY_SUPPLEMENT

Pill form, equivalent to 20 mg elemental zinc, to be given once per day for 14 days

Zinc therapy

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years of age
• Lives in study villages

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Saint Louis Nutrition Project

Blantyre, Malawi

Location

Related Publications (1)

• Ryan KN, Stephenson KB, Trehan I, Shulman RJ, Thakwalakwa C, Murray E, Maleta K, Manary MJ. Zinc or albendazole attenuates the progression of environmental enteropathy: a randomized controlled trial. Clin Gastroenterol Hepatol. 2014 Sep;12(9):1507-13.e1. doi: 10.1016/j.cgh.2014.01.024. Epub 2014 Jan 22.

  PMID: 24462483 DERIVED

MeSH Terms

Conditions

Intestinal Diseases

Interventions

Albendazole; Zinc

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Mark J Manary, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2011
• First Posted: September 26, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 6, 2012

Record last verified: 2012-03

Locations

MA (1)