Effect of a Phosphate Modified Diet on Phosphate Balance and Phosphate Metabolism in Predialysis Patients Stage 3-4

Chronic Kidney Disease Clinical Trial

Official title:

Effect of a Phosphate Modified Diet on Phosphate Balance and Phosphate Metabolism in Predialysis Patients Stage 3-4

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02073136
• Other study ID #: H-1-2013-106
• Status: Completed
• Phase: N/A
• First received: February 25, 2014
• Last updated: July 17, 2014
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Diet with phosphate containing additives

• Diet without phosphate containing additives

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev	Herlev Ringvej 75

Sponsors (4)

Lead Sponsor	Collaborator
University of Copenhagen	Camilla Storm Slumstrup, Casper Rydahl, Ewa Lewin

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phosphate balance		1 week	No
Secondary	p-phosphate		1 week	No
Secondary	p-PTH		1 week	No
Secondary	p-Calcium		1 week	No
Secondary	FGF23		1 week	No
Secondary	p-25(OH)D		1 week	No
Secondary	Calcium-phosphate product		1 week	No
Secondary	p-alkaline phosphatase		1 week	No