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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01440608
Recruitment Status : Completed
First Posted : September 26, 2011
Last Update Posted : March 6, 2012
Information provided by (Responsible Party):

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

Study Design

Study Type : Interventional  (Clinical Trial)
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 : October 2011
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Albendazole
U.S. FDA Resources

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. [ Time Frame: 4 weeks, 7 weeks ]

Secondary Outcome Measures :
  1. Change in blood endoCAb [ Time Frame: 7 weeks ]
  2. Change in fecal calprotectin mRNA [ Time Frame: 4 weeks, 7 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 3 Years   (Child)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440608

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01440608     History of Changes
Other Study ID Numbers: MJM-zincalbendazole
First Posted: September 26, 2011    Key Record Dates
Last Update Posted: March 6, 2012
Last Verified: March 2012

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