At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Effect of Resistant Starch Consumption on Zinc Hemostasis in Malawian Children at Risk for Zinc Deficiency
In Brief
A clinical study evaluating Zinc for Enteropathy. Completed, enrolled 20 participants across 1 site.
Detailed Summary
Broad - to examine the result of feeding RS to 3-5 year old rural Malawian children on zinc homeostasis and environmental enteropathy (EE). Specific - 1. To measure zinc status using a dual zinc stable isotope assay before and after administering resistant starch (RS) in 20 children. 2. To measure intestinal function using a site-specific sugar absorption test before and after administering RS in 20 children. 3. To determine the relationship between RS and zinc homeostasis. 4. To determine the relationship between RS and environmental enteropathy.
Study Details
Timeline
Interventions
Children will have an assessment of zinc homeostasis; each child is given 2 zinc stable isotopes, one by mouth and one intravenously, followed by a stool and urine collection (4 days.) Zinc isotopes are quantified in the feces and urine, values are used to calculate the primary outcome, net zinc balance. An assessment of EE quantitatively measured using the non-invasive site specific sugar absorption test, each child drinks 100 mL of a sugar solution and a urine collection follows. The quantities of non-metabolizable sugars are measured, and the ratio of two of the sugars, lactulose and mannitol, is a measure of environmental enteropathy. Children will receive a dietary supplement, corn starch, modified to reduce its absorption, for 5 weeks, which they will add to their phala. The RS is a standard food and has been used safely in millions of people for years. After taking this RS for 4 weeks both the zinc stable isotope test and the dual sugar absorption test will be repeated.