Effect of a Phosphate Modified Diet on Phosphate Balance and Phosphate Metabolism in Predialysis Patients Stage 3-4
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Diet with phosphate containing additives
Diet without phosphate containing additives
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria:
- Patients > 18 years.
- Diagnosed with Chronic Kidney Disease stage 3-4 (GFR 15-59 ml / min)
- p-phosphate between 0.85 mmol / L (2.7 mg / dL) and 1.50 mmol / L (4.7 mg / dl)
- Read and understand Danish
- Have received oral and written information about the study
- Signed informed consent form
Exclusion Criteria:
- Diagnosed hyperphosphatemia
- Diagnosed hyperparathyroidism
- Treatment with phosphate binders
- Dysphagia
- Diagnosed with decreased absorption capacity in the intestine
- Co-morbidities in liver, pancreas or lungs
- Dementia
- Pregnancy / breastfeeding
- Embedded within the last 4 weeks
- Kidney transplant
- Terminal patients
Sites / Locations
- Herlev Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Phosphate modified diet
Arm Description
Outcomes
Primary Outcome Measures
Phosphate balance
Secondary Outcome Measures
p-phosphate
p-PTH
p-Calcium
FGF23
p-25(OH)D
Calcium-phosphate product
p-alkaline phosphatase
Full Information
NCT ID
NCT02073136
First Posted
February 25, 2014
Last Updated
July 17, 2014
Sponsor
University of Copenhagen
Collaborators
Camilla Storm Slumstrup, Ewa Lewin, Casper Rydahl
1. Study Identification
Unique Protocol Identification Number
NCT02073136
Brief Title
Effect of a Phosphate Modified Diet on Phosphate Balance and Phosphate Metabolism in Predialysis Patients Stage 3-4
Official Title
Effect of a Phosphate Modified Diet on Phosphate Balance and Phosphate Metabolism in Predialysis Patients Stage 3-4
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Camilla Storm Slumstrup, Ewa Lewin, Casper Rydahl
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with chronic kidney disease struggle to eliminate phosphate as the renal function deteriorates, which results in accumulation of phosphate in the body. This has been shown to increase the patients' risk of cardiovascular disease and death. Even with dialysis treatment the patients cannot excrete enough phosphate to reach phosphate balance. The patients are therefore recommended a very restrictive diet when they reach the dialysis stage. It is therefore important to find ways to prevent such accumulation of phosphate in the body as early in the disease process as possible, but without compromising the nutritional status. Because phosphate occurs naturally in many of our foods, such as meat, fish and dairy products, it is difficult to reduce the intake of phosphate, without also reducing the intake of energy and protein. Over the past couple of years there has been an increased focus on the use of phosphate containing additives in the food industry. A reduction in the intake of phosphorus containing additives may reduce the accumulation of phosphate in the body. This can be achieved by decreasing the intake of processed food products. Because it is also very time consuming and inconvenient for the patient to keep these strict diets, the patients have a reasonable claim to know which effects can be achieved by such diets. This will therefore seek to be further explored in the following study. The study is conducted as a randomised crossover trial in predialysis patients stage 3-4.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phosphate modified diet
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Diet with phosphate containing additives
Intervention Type
Other
Intervention Name(s)
Diet without phosphate containing additives
Primary Outcome Measure Information:
Title
Phosphate balance
Time Frame
1 week
Secondary Outcome Measure Information:
Title
p-phosphate
Time Frame
1 week
Title
p-PTH
Time Frame
1 week
Title
p-Calcium
Time Frame
1 week
Title
FGF23
Time Frame
1 week
Title
p-25(OH)D
Time Frame
1 week
Title
Calcium-phosphate product
Time Frame
1 week
Title
p-alkaline phosphatase
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients > 18 years.
Diagnosed with Chronic Kidney Disease stage 3-4 (GFR 15-59 ml / min)
p-phosphate between 0.85 mmol / L (2.7 mg / dL) and 1.50 mmol / L (4.7 mg / dl)
Read and understand Danish
Have received oral and written information about the study
Signed informed consent form
Exclusion Criteria:
Diagnosed hyperphosphatemia
Diagnosed hyperparathyroidism
Treatment with phosphate binders
Dysphagia
Diagnosed with decreased absorption capacity in the intestine
Co-morbidities in liver, pancreas or lungs
Dementia
Pregnancy / breastfeeding
Embedded within the last 4 weeks
Kidney transplant
Terminal patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens R Andersen, MD, MPA
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev Hospital
City
Herlev
State/Province
Herlev Ringvej 75
ZIP/Postal Code
2730
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Effect of a Phosphate Modified Diet on Phosphate Balance and Phosphate Metabolism in Predialysis Patients Stage 3-4
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