Combined Package of Interventions for Environmental Enteropathy

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT02253095
Collaborator
University of Malawi (Other)
253
1
2
6
42.3

Study Details

Study Description

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
  • Drug: Albendazole
  • Dietary Supplement: Zinc
  • Dietary Supplement: Multiple Micronutrient Supplement
  • Drug: Placebo
N/A

Study Design

Study Type:
Interventional
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 :
Oct 1, 2014
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Apr 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Dual Sugar Absorption Test [12 weeks]

    lactulose-mannitol ratio in urine

  2. Dual Sugar Absorption Test [24 weeks]

    lactulose-mannitol ratio in urine

Secondary Outcome Measures

  1. Lactulose Excretion [12 weeks]

    percentage of ingested lactulose excreted in urine

  2. Lactulose Excretion [24 weeks]

    percentage of ingested lactulose excreted in urine

  3. Mannitol Excretion [12 weeks]

    percentage of ingested mannitol excreted in urine

  4. Mannitol Excretion [24 weeks]

    percentage of ingested mannitol excreted in urine

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Months to 35 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Limela Rural Site Limela Machinga Distric Malawi

Sponsors and Collaborators

  • Washington University School of Medicine
  • University of Malawi

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02253095
Other Study ID Numbers:
  • EE-zinc-alb-micronut
First Posted:
Oct 1, 2014
Last Update Posted:
Jun 3, 2015
Last Verified:
Jun 1, 2015

Study Results

No Results Posted as of Jun 3, 2015