Cardiovascular OutcomeNCT00874380
Fiber Intake in an End Stage Renal Disease (ESRD) Population Followed Over 2 Years
An observational study of Cardiovascular Outcome and Kalemia Control, run by Northwell Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Outcome, Kalemia Control, Lipid Profile
- What is being tested?
- Increasing total fiber intake in patient's diet
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ESRD
Who may be able to join
- Patients with end stage renal disease on hemodialysis
- Patients who are able to give informed consent
Who cannot join
- Pregnant women.
- Cognitively impaired patients
- PEG feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Staten Island University Hospital
Staten Island, New York, 10305
About this study
Official title: 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.
- Conditions
- Cardiovascular Outcome, Kalemia Control, Lipid Profile
- Being tested
- Increasing total fiber intake in patient's diet
- Keywords
- Fiber, Dialysis, Renal Replacement Therapy, Food Frequency Questionnaire, FFQ, Dietary counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increasing total fiber intake in patient's dietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | First describe the diet of a cohort of dialysis patients with focus on fiber content. Receives: Other: Increasing total fiber intake in patient's diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular event
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startOct 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular OutcomeStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Staten Island University Hospital
- Responsible party
- Principal investigator, Suzanne El-Sayegh, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874380
- Sponsor's protocol ID
- 08-036
- Status last verified
- May 2013
- First submitted
- 1 Apr 2009
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fiber Content of Hemodialysis Patients' Diet and it's Cardiovascular Implications.
- ClinicalTrials.gov ID
- NCT00874380
- Acronym / sponsor ID
- 08-036
- Conditions
- Cardiovascular Outcome, Kalemia Control, Lipid Profile
- Keywords
- Fiber, Dialysis, Renal Replacement Therapy, Food Frequency Questionnaire, FFQ, Dietary counseling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Staten Island University Hospital
- Study start
- Oct 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Increasing total fiber intake in patient's dietFirst describe the diet of a cohort of dialysis patients with focus on fiber content. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ESRD
Key inclusion criteria (2 listed)
- Patients with end stage renal disease on hemodialysis
- Patients who are able to give informed consent
Key exclusion criteria (3 listed)
- Pregnant women.
- Cognitively impaired patients
- PEG feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increasing total fiber intake in patient's dietSecond 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. | Other | 1 |
Primary outcome
cardiovascular event
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
Related trials for Cardiovascular Outcome
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Active, not recruitingPhase 2
Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Expression (MATCH - Subprotocol Z1H)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
RecruitingObservational study
Clinical Utility and Outcome Prediction of Cardiovascular Computed Tomography (PREDICT-CT)
Coronary Artery Disease, Coronary Arteriosclerosis
RecruitingObservational study
Correlation Between Clinical Neurological Biomarkers and Rehabilitation Outcome
Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Outcome and Kalemia Control, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular event (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2013; AzTrials last refreshed its copy on 7 Nov 2026.