Environmental Enteropathy Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled Trial Evaluating the Impact of Micronutrient Supplementation and Fish Oil + Micronutrient Supplementation in the Treatment of Sub-clinical Environmental Enteropathy in Rural Malawian Children
The purpose of this study is to investigate the therapeutic effectiveness of micronutrients (full RDA) and micronutrients + fish oil 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.
Status | Completed |
Enrollment | 225 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 1 Year to 3 Years |
Eligibility |
Inclusion Criteria: - 1-3 years of age - Lives in study villages - Will not move in next 6 months - Caregiver willing to give intervention daily for 6 months Exclusion Criteria: - Unable to drink 20 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 - Caregiver refusal to participate and return for 3 and 6 month follow-ups |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Malawi | Saint Louis Nutrition Project | Blantyre |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
Malawi,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in urine lactulose:mannitol (L:M) ratio following therapy course. | 3 months, 6 months | No | |
Secondary | Changes in the expression of several fecal mRNAs | 3 months, 6 months | No | |
Secondary | Changes in amounts of lactulose and mannitol excreted in the urine as a percentage of the amounts ingested | 3 months, 6 months | No | |
Secondary | Change in height | 3 month, 6 month | No |
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