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Trial record 29 of 110 for:    test | ( Map: Malawi )

Combined Package of Interventions for Environmental Enteropathy

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ClinicalTrials.gov Identifier: NCT02253095
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : June 3, 2015
Sponsor:
Collaborator:
University of Malawi
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
Randomized, double-blind, placebo controlled trial of a combined intervention of zinc, albendazole, and multiple micronutrients in improving environmental enteropathy in Malawian children.

Condition or disease Intervention/treatment Phase
Environmental Enteropathy Drug: Albendazole Dietary Supplement: Zinc Dietary Supplement: Multiple Micronutrient Supplement Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 253 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 Comparing the Impact of a Combined Package of Interventions vs Placebo in the Treatment of Sub-clinical Environmental Enteropathy in Rural Malawian Children
Study Start Date : October 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: Multiple Intervention Arm
single dose albendazole, two weeks of zinc, 24 weeks of multiple micronutrients
Drug: Albendazole
Dietary Supplement: Zinc
Dietary Supplement: Multiple Micronutrient Supplement
Placebo Comparator: Placebo
three placebos
Drug: Placebo



Primary Outcome Measures :
  1. Dual Sugar Absorption Test [ Time Frame: 12 weeks ]
    lactulose-mannitol ratio in urine

  2. Dual Sugar Absorption Test [ Time Frame: 24 weeks ]
    lactulose-mannitol ratio in urine


Secondary Outcome Measures :
  1. Lactulose Excretion [ Time Frame: 12 weeks ]
    percentage of ingested lactulose excreted in urine

  2. Lactulose Excretion [ Time Frame: 24 weeks ]
    percentage of ingested lactulose excreted in urine

  3. Mannitol Excretion [ Time Frame: 12 weeks ]
    percentage of ingested mannitol excreted in urine

  4. Mannitol Excretion [ Time Frame: 24 weeks ]
    percentage of ingested mannitol excreted in urine



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Ages Eligible for Study:   12 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • children residing in catchment area of Limela, Machinga District, Malawi
  • aged 12-35 months
  • youngest eligible child in each household

Exclusion Criteria:

  • severe acute malnutrition
  • severe chronic illness
  • children unable to drink 20 mL of dual sugar solution
  • children in need of acute medical treatment for illness or injury at time of enrollment

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): NCT02253095


Locations
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Malawi
Limela Rural Site
Limela, Machinga Distric, Malawi
Sponsors and Collaborators
Washington University School of Medicine
University of Malawi
Investigators
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Principal Investigator: Mark J Manary, MD Washington University in St. Louis; University of Malawi
Study Director: Chrissie Thakwalakwa, PhD University of Malawi
Study Director: Indi Trehan, MD MPH DTM&H Washington University in St. Louis; University of Malawi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02253095     History of Changes
Other Study ID Numbers: EE-zinc-alb-micronut
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015

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