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

NCT00656279 | Completed

• 1 other identifier: SMH07-377
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

chronic kidney disease; predialysis; hyperphosphatemia; dietary intervention; intensive dietary education; low phosphorus diet

Outcome Measures

Primary Outcomes (1)

• Serum phosphorus

  baseline, week 6, week 12

Secondary Outcomes (3)

• Dietary adherence

  baseline, week 6, week 12

• Dietary satisfaction

  baseline, week 6, week 12

• Phosphorus management knowledge-level

  baseline, week 6, week 12

Study Arms (2)

1

EXPERIMENTAL

Intensive dietary phosphorus education

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.

Interventions

Intensive dietary phosphorus education BEHAVIORAL

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• Currently on dialysis
• Current malignancy
• Inability to use Phosphorus Point System (PPS) Tool

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital Progressive Renal Disease Clinic

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperphosphatemia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Pauline Darling, PhD

  St. Michael's Hospital & University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2008
• First Posted: April 11, 2008
• Study Start: April 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: May 9, 2013

Record last verified: 2013-05

Locations

CA (1)