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Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01186276
First received: August 19, 2010
Last updated: March 5, 2012
Last verified: March 2012
History of Changes

August 19, 2010
March 5, 2012
July 2010
December 2012   (final data collection date for primary outcome measure)
Plasma level of p-cresol sulfate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01186276 on ClinicalTrials.gov Archive Site
Caloric intake [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes
Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Kidney Failure, Chronic
  • Dietary Supplement: Fiber
    Dietary fiber supplements to be consumed daily for 6 weeks.
  • Dietary Supplement: Corn starch
    Corn starch to be consumed daily for 6 weeks. This will serve as the control/placebo arm.
  • Placebo Comparator: Corn Starch
    Corn starch will serve as the control arm.
    Intervention: Dietary Supplement: Corn starch
  • Experimental: Fiber
    Fiber will serve as the intervention.
    Intervention: Dietary Supplement: Fiber
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01186276
SU-07292010-6626, NIH R21AT005123-01A1
Not Provided
Stanford University
Stanford University
National Institutes of Health (NIH)
Principal Investigator: Timothy W Meyer Stanford University
Stanford University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP