Clinical trial NCT00656279: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: chronic kidney disease
predialysis
hyperphosphatemia
dietary intervention
intensive dietary education
low phosphorus diet
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2008-04-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Serum phosphorus
timeFrame: baseline, week 6, week 12
Secondary outcomes:
measure: Dietary adherence
timeFrame: baseline, week 6, week 12
measure: Dietary satisfaction
timeFrame: baseline, week 6, week 12
measure: Phosphorus management knowledge-level
timeFrame: baseline, week 6, week 12
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital Progressive Renal Disease Clinic
state: Ontario
Study officials:
affiliation: St. Michael's Hospital & University of Toronto
name: Pauline Darling, PhD
role: PRINCIPAL_INVESTIGATOR
References: