Clinical trial NCT02073136: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Camilla Storm Slumstrup
name: Ewa Lewin
name: Casper Rydahl
First posted: 2014-02-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Phosphate balance
timeFrame: 1 week
Secondary outcomes:
measure: p-phosphate
timeFrame: 1 week
measure: p-PTH
timeFrame: 1 week
measure: p-Calcium
timeFrame: 1 week
measure: FGF23
timeFrame: 1 week
measure: p-25(OH)D
timeFrame: 1 week
measure: Calcium-phosphate product
timeFrame: 1 week
measure: p-alkaline phosphatase
timeFrame: 1 week
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
state: Herlev Ringvej 75
Study officials:
affiliation: University of Copenhagen
name: Jens R Andersen, MD, MPA
role: PRINCIPAL_INVESTIGATOR
References: