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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01440608

Enrollment

225

Registered

2011-09-26

Start date

2011-10-31

Completion date

2011-12-31

Last updated

2012-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enteropathy

Brief summary

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.

Interventions

DRUGAlbendazole

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

DRUGPlacebo

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.

DIETARY_SUPPLEMENTHigh-dose Zinc

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Years to 3 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Changes in urine lactulose:mannitol (L:M) ratio following therapy course.	4 weeks, 7 weeks

Secondary

Measure	Time frame
Change in blood endoCAb	7 weeks
Change in fecal calprotectin mRNA	4 weeks, 7 weeks

Countries

Malawi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026