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Completed

NCT Number: NCT01440608

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

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.

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Key information

Conditions

Enteropathy Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

1 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Louis Nutrition Project

Blantyre, Malawi

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Albendazole

Drug

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

Drug

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.

High-dose Zinc

Dietary Supplement

Pill form, equivalent to 20 mg elemental zinc, to be given once per day for 14 days

Primary outcomes

  1. Changes in urine lactulose:mannitol (L:M) ratio following therapy course.

    Time frame: 4 weeks, 7 weeks

Secondary outcomes

  1. Change in blood endoCAb

    Time frame: 7 weeks

  2. Change in fecal calprotectin mRNA

    Time frame: 4 weeks, 7 weeks

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 26, 2011
Registry last updated
Mar 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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