- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00874380
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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Staten Island, New York, United States, 10305
- Staten Island University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
First describe the diet of a cohort of dialysis patients with focus on fiber content.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
cardiovascular event
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 08-036
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