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NCT01186276 Clinical Trial

Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes

Kidney Failure, Chronic Clinical Trial

Official title:
Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01186276
Other study ID # SU-07292010-6626
Secondary ID NIH R21AT005123-
Status Completed
Phase N/A
First received
Last updated
Start date July 2010
Est. completion date September 2015

Study information
Verified date August 2022
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will assess whether dietary fiber supplements can reduce the production of chemicals which are produced by colon bacteria and normally excreted from the body by the kidney, but build up in the body in patients on hemodialysis.

Description:

The study procedures will consist of: - taking a dietary supplement containing either fiber or starch (starch serves as a control for fiber) for six weeks. The fiber dose initially employed will be 30 g/day of high amylose corn and the control starch dose employed will be 30 g/day of waxy corn starch. Supplements which come in dry powder form will be mixed in liquid or food for consumption. - filling out a food record and a quality of life questionnaire - keeping a diary of any gi symptoms - collecting samples of blood, spent dialysate, urine(if the patient still makes urine) and stool.

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - stable dialysis patients able to provide consent. Exclusion Criteria:-- known g.i. disease - use of antibiotics for the last two month or expected antibiotic use - recent hospitalization or other event resulting in instability of food intake

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Fiber
Dietary fiber supplements to be consumed daily for 6 weeks.
• Corn starch
Corn starch to be consumed daily for 6 weeks. This will serve as the control/placebo arm.

Locations
Country Name City State
United States VA Palo Alto Health Care System Palo Alto California
United States Satellite Dialysis Redwood City California
United States SCVMC San Jose California

Sponsors (2)
Lead Sponsor Collaborator
Stanford University National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma level of p-cresol sulfate 8 weeks
Secondary Caloric intake 8 weeks
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