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Completed

NCT Number: NCT02253095

Combined Package of Interventions for Environmental Enteropathy

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

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Key information

Conditions

Environmental Enteropathy

Age range

12 month–35 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Limela Rural Site

Limela, Machinga Distric, Malawi

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Albendazole

Drug

Zinc

Dietary Supplement

Multiple Micronutrient Supplement

Dietary Supplement

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • University of Malawi

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 1, 2014
Registry last updated
Jun 3, 2015

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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