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

Sponsor

Northwell Health (Other)

Overall Status

Completed

CT.gov ID

NCT00874380

Collaborator

Staten Island University Hospital (Other)

Enrollment

Location

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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	Phase
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 :

Oct 1, 2008

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
1 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.

Arm

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

cardiovascular event [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Staten Island University Hospital	Staten Island	New York	United States	10305

Sponsors and Collaborators

Northwell Health
Staten Island University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suzanne El-Sayegh, Nephrology Attending, Assoc. Chair of Medicine, Northwell Health

ClinicalTrials.gov Identifier:

NCT00874380

Other Study ID Numbers:

08-036

First Posted:

Apr 2, 2009

Last Update Posted:

May 15, 2013

Last Verified:

May 1, 2013

Keywords provided by Suzanne El-Sayegh, Nephrology Attending, Assoc. Chair of Medicine, Northwell Health

Fiber

Dialysis

Renal Replacement Therapy

Food Frequency Questionnaire

FFQ

Dietary counseling

Study Results

No Results Posted as of May 15, 2013