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Fiber Intake in an End Stage Renal Disease (ESRD) Population Followed Over 2 Years

This study has been completed.
Sponsor:
Collaborator:
Staten Island University Hospital
Information provided by (Responsible Party):
Suzanne El-Sayegh, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00874380
First received: April 1, 2009
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

Our research involves the detailed description of the content of the diet of x dialysis patients.

For our purpose we used a newly developed "food frequency questionnaire". This is the first validated questionnaire specific for dialysis patients and we were the first to use it.

Our special focus was the fiber content in the diet of our patient. Our thesis that they are way below the recommended guidelines for fiber intake was verified. Our follow will evaluate the effect of such at diet, mosTLy cardiovascular.


Condition Intervention
Cardiovascular Outcome
Kalemia Control
Lipid Profile
 Other: Increasing total fiber intake in patient's diet

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fiber Content of Hemodialysis Patients' Diet and it's Cardiovascular Implications.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • cardiovascular event [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: October 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
First describe the diet of a cohort of dialysis patients with focus on fiber content.
 Other: Increasing total fiber intake in patient's diet
Second counsel patients biweekly about their compliance with a high fiber diet, target being 25 to 30 gm of fiber a day.Follow them for a period of 2 years and assess if their is any significant decrease in their cardiovascular events and profile, in addition to assessing the effect of high fiber on kalemia.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ESRD

Criteria

Inclusion Criteria:

  • Patients with end stage renal disease on hemodialysis
  • Patients who are able to give informed consent

Exclusion Criteria:

  • Pregnant women.
  • Cognitively impaired patients
  • PEG feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874380

Locations
United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Staten Island University Hospital
  More Information

No publications provided

Responsible Party: Suzanne El-Sayegh, Nephrology Attending, Assoc. Chair of Medicine, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00874380     History of Changes
Other Study ID Numbers: 08-036
Study First Received: April 1, 2009
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Fiber
Dialysis
Renal Replacement Therapy
 Food Frequency Questionnaire
FFQ
Dietary counseling

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

ClinicalTrials.gov processed this record on May 22, 2013