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

NCT ID: NCT02073136

Last Updated: 2014-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-07-31

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.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phosphate modified diet

Group Type: EXPERIMENTAL

Diet with phosphate containing additives

Intervention Type: OTHER

Diet without phosphate containing additives

Intervention Type: OTHER

Interventions

Diet with phosphate containing additives

Intervention Type: OTHER

Diet without phosphate containing additives

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Camilla Storm Slumstrup

UNKNOWN

Sponsor Role: collaborator

Ewa Lewin

UNKNOWN

Sponsor Role: collaborator

Casper Rydahl

UNKNOWN

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Jens Rikardt Andersen

Associate professor at the University of Copenhagen

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jens R Andersen, MD, MPA

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

Herlev Hospital

Herlev, Herlev Ringvej 75, Denmark

Countries

Denmark

Other Identifiers

H-1-2013-106

Identifier Type: -

Identifier Source: org_study_id