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

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Behavioral: Intensive dietary phosphorus education

• Registration Number: NCT00656279
• Lead Sponsor: Unity Health 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.

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 Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-07
• Study First Submitted QC: 2008-04-07
• Study First Posted: 2008-04-11
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-07
• Last Update Posted: 2013-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Intensive dietary phosphorus education	Intensive dietary phosphorus education

Primary Outcome Measures

Name	Time	Method
Serum phosphorus	baseline, week 6, week 12

Secondary Outcome Measures

Name	Time	Method
Dietary adherence	baseline, week 6, week 12
Phosphorus management knowledge-level	baseline, week 6, week 12
Dietary satisfaction	baseline, week 6, week 12

Trial Locations

Locations (1)

St. Michael's Hospital Progressive Renal Disease Clinic; 🇨🇦 Toronto, Ontario, Canada