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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01440608
First received: September 22, 2011
Last updated: March 2, 2012
Last verified: March 2012
  Purpose

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 Intervention
Enteropathy
Drug: Albendazole
Drug: Placebo
Dietary Supplement: High-dose Zinc

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Changes in urine lactulose:mannitol (L:M) ratio following therapy course. [ Time Frame: 4 weeks, 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in blood endoCAb [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Change in fecal calprotectin mRNA [ Time Frame: 4 weeks, 7 weeks ] [ Designated as safety issue: No ]

Enrollment: 225
Study Start Date: October 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   1 Year to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440608

Locations
Malawi
Saint Louis Nutrition Project
Blantyre, Malawi
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Mark J Manary, MD Washington University in St. Louis, School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01440608     History of Changes
Other Study ID Numbers: MJM-zincalbendazole
Study First Received: September 22, 2011
Last Updated: March 2, 2012
Health Authority: United States: Institutional Review Board
Malawi: College of Medicine Research and Ethics Committee

Additional relevant MeSH terms:
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Albendazole
Zinc
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014