Chronic Kidney DiseaseNCT00656279
Intensive Dietary Education to Lower Serum Phosphorus in Patients With Chronic Kidney Disease
A study testing Intensive dietary phosphorus education in people with Chronic Kidney Disease, run by Unity Health Toronto at 1 site in Canada.
Trial summary
A low phosphorus diet is recommended for patients with chronic kidney disease who exhibit high levels of phosphorus. The purpose of this study is to determine the effects of a more intensive, innovative dietary phosphorus educational intervention on reducing serum phosphorus levels, as well as improving dietary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Intensive dietary phosphorus education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2008to Jul 2009
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- Patient with pre-dialysis CKD attending the Progressive Renal Disease Clinic (PRDC) at St. Michael's Hospital
- Six-month mean serum phosphorus > 1.35 mmol/L
- Able to provide informed consent
Who cannot join
- Currently on dialysis
- Current malignancy
- Inability to use Phosphorus Point System (PPS) Tool
Trial locations and contacts
1 site in 1 country.
Canada1 site
St. Michael's Hospital Progressive Renal Disease Clinic
Toronto, Ontario, M5B 1W8
About this study
Official title: Intensive Patient Education Using the Phosphorus Point System© Tool to Improve Serum Phosphorus Levels in Patients With Chronic Kidney Disease
A low phosphorus diet is recommended for patients with chronic kidney disease who exhibit high levels of phosphorus. The purpose of this study is to determine the effects of a more intensive, innovative dietary phosphorus educational intervention on reducing serum phosphorus levels, as well as improving dietary adherence, dietary satisfaction and phosphorus knowledge level in patients with chronic kidney disease.
Read the detailed description
High serum phosphorus concentration (hPhos) commonly occurs in chronic kidney disease (CKD) secondary to declining renal function. hPhos increases the risk of developing metastatic calcification, secondary hyperparathyroidism, renal osteodystrophy and cardiovascular complications. Patients with hPhos are advised to restrict their dietary phosphorus intake to 800-1000mg/d, as per National Kidney Foundations'Kidney Disease Quality Outcomes Initiative (KDOQI). Adherence to a phosphorus restricted diet is often challenging for CKD patients, as they may be required to follow various dietary restrictions, and there is significant quantities of hidden phosphorus in processed foods. This randomized controlled trial is designed to compare the effectiveness of more intensive phosphorus education (IPE) using the innovative Phosphorus Point System Tool© versus standard phosphorus education (SPE) using the Choose/Avoid list on 1) serum phosphorus levels (primary outcome) 2) dietary adherence, dietary knowledge and satisfaction in patients with pre-dialysis CKD. We hypothesize that patients receiving IPE will have lower serum phosphorus than those receiving SPE. Fifty patients attending a pre-dialysis CKD clinic with serum phosphorus > 1.49 mmol/L will be randomly assigned to IPE or SPE and followed over 12 weeks. Serum phosphorus, dietary intakes using the 5-pass repeat 24-hour dietary recall method, dietary knowledge and satisfaction by validated questionnaires, will be measured at baseline, 6 weeks and 12 weeks. The study's findings on the impact of more intensive innovative dietary phosphorus education in patients with pre-dialysis CKD will serve towards developing best practice of care and potentially reduce long-term complications.
- Conditions
- Chronic Kidney Disease
- Being tested
- Intensive dietary phosphorus education
- Keywords
- chronic kidney disease, predialysis, hyperphosphatemia, dietary intervention, intensive dietary education, low phosphorus diet
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive dietary phosphorus educationBehavioural
Intensive dietary phosphorus education will be completed using the Phosphorus Point System Tool, a booklet listing phosphorus points for food items based on the phosphorus content. Patients will be allotted a maximum of 32-40 phosphorus points daily. Points consumed will be tracked by the patients via daily tracking sheets which require patients to list the phosphorus food items consumed, the number of points, and the time and amount of phosphate binders. Patients in this group will also receive intensive education about phosphorus additives. As a part of the program that supports the tool, patients will receive weekly telephone calls for the first 6 weeks to address any questions about the tool and find phosphorus point values of foods not listed within the tool.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intensive dietary phosphorus education Receives: Behavioral: Intensive dietary phosphorus education |
| 2 | No intervention | Standard dietary education consists of the dietitian assessing laboratory values and dietary intake and providing dietary education for abnormal values using handouts developed for specific nutrients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum phosphorus
Measured: baseline, week 6, week 12
Secondary outcomes (3)
Dietary adherence
Measured: baseline, week 6, week 12
Dietary satisfaction
Measured: baseline, week 6, week 12
Phosphorus management knowledge-level
Measured: baseline, week 6, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline Darling, PhD, Principal investigator, St. Michael's Hospital & University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656279
- Sponsor's protocol ID
- SMH07-377
- Status last verified
- May 2013
- First submitted
- 7 Apr 2008
- Last updated
- 9 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Patient Education Using the Phosphorus Point System© Tool to Improve Serum Phosphorus Levels in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT00656279
- Acronym / sponsor ID
- SMH07-377
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease, predialysis, hyperphosphatemia, dietary intervention, intensive dietary education, low phosphorus diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 11 Apr 2008 (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.
A low phosphorus diet is recommended for patients with chronic kidney disease who exhibit high levels of phosphorus. The purpose of this study is to determine the effects of a more intensive, innovative dietary phosphorus educational intervention on reducing serum phosphorus levels, as well as improving dietary adherence, dietary satisfaction and phosphorus knowledge level in patients with chronic kidney disease.
Detailed description
High serum phosphorus concentration (hPhos) commonly occurs in chronic kidney disease (CKD) secondary to declining renal function. hPhos increases the risk of developing metastatic calcification, secondary hyperparathyroidism, renal osteodystrophy and cardiovascular complications. Patients with hPhos are advised to restrict their dietary phosphorus intake to 800-1000mg/d, as per National Kidney Foundations'Kidney Disease Quality Outcomes Initiative (KDOQI). Adherence to a phosphorus restricted diet is often challenging for CKD patients, as they may be required to follow various dietary restrictions, and there is significant quantities of hidden phosphorus in processed foods. This randomized controlled trial is designed to compare the effectiveness of more intensive phosphorus education (IPE) using the innovative Phosphorus Point System Tool© versus standard phosphorus education (SPE) using the Choose/Avoid list on 1) serum phosphorus levels (primary outcome) 2) dietary adherence, dietary knowledge and satisfaction in patients with pre-dialysis CKD. We hypothesize that patients receiving IPE will have lower serum phosphorus than those receiving SPE. Fifty patients attending a pre-dialysis CKD clinic with serum phosphorus > 1.49 mmol/L will be randomly assigned to IPE or SPE and followed over 12 weeks. Serum phosphorus, dietary intakes using the 5-pass repeat 24-hour dietary recall method, dietary knowledge and satisfaction by validated questionnaires, will be measured at baseline, 6 weeks and 12 weeks. The study's findings on the impact of more intensive innovative dietary phosphorus education in patients with pre-dialysis CKD will serve towards developing best practice of care and potentially reduce long-term complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Intensive dietary phosphorus educationIntensive dietary phosphorus education |
| 2 | No intervention | –Standard dietary education consists of the dietitian assessing laboratory values and dietary intake and providing dietary education for abnormal values using handouts developed for specific nutrients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years old
- Patient with pre-dialysis CKD attending the Progressive Renal Disease Clinic (PRDC) at St. Michael's Hospital
- Six-month mean serum phosphorus > 1.35 mmol/L
- Able to provide informed consent
Key exclusion criteria (3 listed)
- Currently on dialysis
- Current malignancy
- Inability to use Phosphorus Point System (PPS) Tool
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 |
|---|---|---|
| Intensive dietary phosphorus educationIntensive dietary phosphorus education will be completed using the Phosphorus Point System Tool, a booklet listing phosphorus points for food items based on the phosphorus content. Patients will be allotted a maximum of 32-40 phosphorus points daily. Points consumed will be tracked by the patients via daily tracking sheets which require patients to list the phosphorus food items consumed, the number of points, and the time and amount of phosphate binders. Patients in this group will also receive intensive education about phosphorus additives. As a part of the program that supports the tool, patients will receive weekly telephone calls for the first 6 weeks to address any questions about the tool and find phosphorus point values of foods not listed within the tool. | Behavioural | 1 |
Primary outcome
Serum phosphorus
Time frame: baseline, week 6, week 12
3 secondary outcomes
Dietary adherence
Time frame: baseline, week 6, week 12
Dietary satisfaction
Time frame: baseline, week 6, week 12
Phosphorus management knowledge-level
Time frame: baseline, week 6, week 12
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 9 May 2013.
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
Pauline Darling, PhD principal investigator
St. Michael's Hospital & University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive dietary phosphorus education in people with Chronic Kidney Disease, run by Unity Health Toronto at 1 site in Canada.
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 4 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 9 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 Canada. 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?
Serum phosphorus (time frame: baseline, week 6, week 12). 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 9 May 2013.