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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00874380
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : May 15, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Cardiovascular Outcome Kalemia Control Lipid Profile Other: Increasing total fiber intake in patient's diet

Study Design

Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fiber Content of Hemodialysis Patients' Diet and it's Cardiovascular Implications.
Study Start Date : October 2008
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. cardiovascular event [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874380

United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
Sponsors and Collaborators
Northwell Health
Staten Island University Hospital
More Information

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
First Posted: April 2, 2009    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: May 2013

Keywords provided by Suzanne El-Sayegh, North Shore Long Island Jewish Health System:
Renal Replacement Therapy
Food Frequency Questionnaire
Dietary counseling

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