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Completed

NCT Number: NCT00874380

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

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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Key information

Conditions

Cardiovascular Outcome Kalemia Control Lipid Profile

Sex eligibility

All sexes

Study type

Observational

Primary location

Staten Island University Hospital

Staten Island, New York, 10305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Increasing total fiber intake in patient's diet

Other

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.

Primary outcomes

  1. cardiovascular event

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Staten Island University Hospital

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Apr 2, 2009
Registry last updated
May 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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