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

Lipid Profile Clinical Trial

Official title:

Fiber Content of Hemodialysis Patients' Diet and it's Cardiovascular Implications.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00874380
• Other study ID #: 08-036
• Status: Completed
• Phase: N/A
• First received: April 1, 2009
• Last updated: May 14, 2013
• Start date: October 2008
• Est. completion date: June 2011

Study information

• Verified date: May 2013
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Outcome
• Kalemia Control
• Kidney Failure, Chronic
• Lipid Profile

Intervention

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.

Locations

Country	Name	City	State
United States	Staten Island University Hospital	Staten Island	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Staten Island University Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiovascular event		2 years	No