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

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Other: Diet with phosphate containing additives; Other: Diet without phosphate containing additives

• Registration Number: NCT02073136
• Lead Sponsor: University of Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-25
• Study First Submitted QC: 2014-02-26
• Study First Posted: 2014-02-27
• Study Start: 2014-03
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-17
• Last Update Posted: 2014-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Phosphate modified diet	Diet with phosphate containing additives	-
Phosphate modified diet	Diet without phosphate containing additives	-

Primary Outcome Measures

Name	Time	Method
Phosphate balance	1 week

Secondary Outcome Measures

Name	Time	Method
p-Calcium	1 week
p-phosphate	1 week
p-PTH	1 week
FGF23	1 week
p-alkaline phosphatase	1 week
Calcium-phosphate product	1 week
p-25(OH)D	1 week

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Herlev, Herlev Ringvej 75, Denmark