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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
History of Changes

September 22, 2011
March 2, 2012
October 2011
December 2011   (final data collection date for primary outcome measure)
Changes in urine lactulose:mannitol (L:M) ratio following therapy course. [ Time Frame: 4 weeks, 7 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01440608 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
 
 
Effectiveness of High-dose Zinc Therapy and Albendazole in the Treatment of Environmental Enteropathy
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

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.
 
Interventional
 
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Enteropathy
  • 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
  • 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.
  • Dietary Supplement: High-dose Zinc
    Pill form, equivalent to 20 mg elemental zinc, to be given once per day for 14 days
  • Experimental: Zinc therapy
    High-dose zinc, equivalent 20 mg elemental zinc, to be given once per day for 14 days
    Intervention: Dietary Supplement: High-dose Zinc
  • Experimental: Albendazole
    Albendazole to be given once on the day of enrollment. Placebo will then be given for 13 days following.
    Intervention: Drug: Albendazole
  • Placebo Comparator: Placebo
    Placebo will be given for 14 days
    Intervention: Drug: Placebo
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
225
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
1 Year to 3 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Malawi
 
NCT01440608
MJM-zincalbendazole
 
Washington University School of Medicine
Washington University School of Medicine
 
Principal Investigator: Mark J Manary, MD Washington University in St. Louis School of Medicine
Washington University School of Medicine
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP