Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
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
  Purpose

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.


Condition Intervention
Kidney Failure, Chronic
Dietary Supplement: Fiber
Dietary Supplement: Corn starch

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Plasma level of p-cresol sulfate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Caloric intake [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Corn Starch
Corn starch will serve as the control arm.
Dietary Supplement: Corn starch
Corn starch to be consumed daily for 6 weeks. This will serve as the control/placebo arm.
Experimental: Fiber
Fiber will serve as the intervention.
Dietary Supplement: Fiber
Dietary fiber supplements to be consumed daily for 6 weeks.

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186276

Locations
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Satellite Dialysis
Redwood City, California, United States, 94063
SCVMC
San Jose, California, United States, 95128
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Timothy W Meyer Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01186276     History of Changes
Other Study ID Numbers: SU-07292010-6626, NIH R21AT005123-01A1
Study First Received: August 19, 2010
Last Updated: March 5, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 28, 2014