Combined Package of Interventions for Environmental Enteropathy

Environmental Enteropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02253095
• Other study ID #: EE-zinc-alb-micronut
• Status: Completed
• Phase: N/A
• First received: September 26, 2014
• Last updated: June 2, 2015
• Start date: October 2014
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malawi: College of Medicine Research and Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 35 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Environmental Enteropathy
• Intestinal Diseases

Intervention

Drug:
• Albendazole

Dietary Supplement:
• Zinc

• Multiple Micronutrient Supplement

Drug:
• Placebo

Locations

Country	Name	City	State
Malawi	Limela Rural Site	Limela	Machinga Distric

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	University of Malawi

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dual Sugar Absorption Test	lactulose-mannitol ratio in urine	12 weeks	No
Primary	Dual Sugar Absorption Test	lactulose-mannitol ratio in urine	24 weeks	No
Secondary	Lactulose Excretion	percentage of ingested lactulose excreted in urine	12 weeks	No
Secondary	Lactulose Excretion	percentage of ingested lactulose excreted in urine	24 weeks	No
Secondary	Mannitol Excretion	percentage of ingested mannitol excreted in urine	12 weeks	No
Secondary	Mannitol Excretion	percentage of ingested mannitol excreted in urine	24 weeks	No