Combined Package of Interventions for Environmental Enteropathy

June 2, 2015 updated by: Washington University School of Medicine

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

253

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malawi
    • Machinga Distric
      • Limela, Machinga Distric, Malawi
        • Limela Rural Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dual Sugar Absorption Test
Time Frame: 12 weeks
lactulose-mannitol ratio in urine
12 weeks
Dual Sugar Absorption Test
Time Frame: 24 weeks
lactulose-mannitol ratio in urine
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lactulose Excretion
Time Frame: 12 weeks
percentage of ingested lactulose excreted in urine
12 weeks
Lactulose Excretion
Time Frame: 24 weeks
percentage of ingested lactulose excreted in urine
24 weeks
Mannitol Excretion
Time Frame: 12 weeks
percentage of ingested mannitol excreted in urine
12 weeks
Mannitol Excretion
Time Frame: 24 weeks
percentage of ingested mannitol excreted in urine
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

University of Malawi

Investigators

  • Study Director: Chrissie Thakwalakwa, PhD, University of Malawi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

September 26, 2014

First Submitted That Met QC Criteria

September 30, 2014

First Posted (ESTIMATE)

October 1, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 3, 2015

Last Update Submitted That Met QC Criteria

June 2, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EE-zinc-alb-micronut

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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