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

April 1, 2009
May 14, 2013
October 2008
June 2011   (final data collection date for primary outcome measure)
cardiovascular event [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00874380 on ClinicalTrials.gov Archive Site
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Fiber Intake in an End Stage Renal Disease (ESRD) Population Followed Over 2 Years
Fiber Content of Hemodialysis Patients' Diet and it's Cardiovascular Implications.

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

ESRD

  • Cardiovascular Outcome
  • Kalemia Control
  • Lipid Profile
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.
1
First describe the diet of a cohort of dialysis patients with focus on fiber content.
Intervention: Other: Increasing total fiber intake in patient's diet
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00874380
08-036
No
Suzanne El-Sayegh, North Shore Long Island Jewish Health System
North Shore Long Island Jewish Health System
Staten Island University Hospital
Not Provided
North Shore Long Island Jewish Health System
May 2013

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