Intensive Dietary Education to Lower Serum Phosphorus in Patients With Chronic Kidney Disease
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intensive dietary phosphorus education
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Kidney Disease focused on measuring chronic kidney disease, predialysis, hyperphosphatemia, dietary intervention, intensive dietary education, low phosphorus diet
Eligibility Criteria
Inclusion Criteria:
- ≥ 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
Exclusion Criteria:
- Currently on dialysis
- Current malignancy
- Inability to use Phosphorus Point System (PPS) Tool
Sites / Locations
- St. Michael's Hospital Progressive Renal Disease Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Intensive dietary phosphorus education
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.
Outcomes
Primary Outcome Measures
Serum phosphorus
Secondary Outcome Measures
Dietary adherence
Dietary satisfaction
Phosphorus management knowledge-level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00656279
Brief Title
Intensive Dietary Education to Lower Serum Phosphorus in Patients With Chronic Kidney Disease
Official Title
Intensive Patient Education Using the Phosphorus Point System© Tool to Improve Serum Phosphorus Levels in Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
chronic kidney disease, predialysis, hyperphosphatemia, dietary intervention, intensive dietary education, low phosphorus diet
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Intensive dietary phosphorus education
Arm Title
2
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intensive dietary phosphorus education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum phosphorus
Time Frame
baseline, week 6, week 12
Secondary Outcome Measure Information:
Title
Dietary adherence
Time Frame
baseline, week 6, week 12
Title
Dietary satisfaction
Time Frame
baseline, week 6, week 12
Title
Phosphorus management knowledge-level
Time Frame
baseline, week 6, week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 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
Exclusion Criteria:
Currently on dialysis
Current malignancy
Inability to use Phosphorus Point System (PPS) Tool
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pauline Darling, PhD
Organizational Affiliation
St. Michael's Hospital & University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital Progressive Renal Disease Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
12. IPD Sharing Statement
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Intensive Dietary Education to Lower Serum Phosphorus in Patients With Chronic Kidney Disease
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