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Zinc Resistant Starch Project

NCT01811836 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-08-02

No results posted yet for this study

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.

Conditions

  • Enteropathy

Interventions

DIETARY_SUPPLEMENT

Zinc

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.

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Mark Manary, MD · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
36 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Malawi

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01811836 on ClinicalTrials.gov