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.
1 other identifier
observational
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2008
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 1, 2009
CompletedFirst Posted
Study publicly available on registry
April 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedMay 15, 2013
May 1, 2013
2.7 years
April 1, 2009
May 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cardiovascular event
2 years
Study Arms (1)
1
First describe the diet of a cohort of dialysis patients with focus on fiber content.
Interventions
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 Criteria
ESRD
You may qualify if:
- Patients with end stage renal disease on hemodialysis
- Patients who are able to give informed consent
You may not qualify if:
- Pregnant women.
- Cognitively impaired patients
- PEG feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwell Healthlead
- Staten Island University Hospitalcollaborator
Study Sites (1)
Staten Island University Hospital
Staten Island, New York, 10305, United States
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nephrology Attending, Assoc. Chair of Medicine
Study Record Dates
First Submitted
April 1, 2009
First Posted
April 2, 2009
Study Start
October 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
May 15, 2013
Record last verified: 2013-05