Intensive Dietary Education to Lower Serum Phosphorus in Patients With Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00656279
Recruitment Status : Completed
First Posted : April 11, 2008
Last Update Posted : May 9, 2013
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Behavioral: Intensive dietary phosphorus education Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Intensive Patient Education Using the Phosphorus Point System© Tool to Improve Serum Phosphorus Levels in Patients With Chronic Kidney Disease
Study Start Date : April 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Phosphorus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Intensive dietary phosphorus education
Behavioral: Intensive dietary phosphorus education
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.
No Intervention: 2
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.

Primary Outcome Measures :
  1. Serum phosphorus [ Time Frame: baseline, week 6, week 12 ]

Secondary Outcome Measures :
  1. Dietary adherence [ Time Frame: baseline, week 6, week 12 ]
  2. Dietary satisfaction [ Time Frame: baseline, week 6, week 12 ]
  3. Phosphorus management knowledge-level [ Time Frame: baseline, week 6, week 12 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00656279

Canada, Ontario
St. Michael's Hospital Progressive Renal Disease Clinic
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Principal Investigator: Pauline Darling, PhD St. Michael's Hospital & University of Toronto

Responsible Party: St. Michael's Hospital, Toronto Identifier: NCT00656279     History of Changes
Other Study ID Numbers: SMH07-377
First Posted: April 11, 2008    Key Record Dates
Last Update Posted: May 9, 2013
Last Verified: May 2013

Keywords provided by St. Michael's Hospital, Toronto:
chronic kidney disease
dietary intervention
intensive dietary education
low phosphorus diet

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency