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

University of Copenhagen

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Other: Diet with phosphate containing additives; Other: Diet without phosphate containing additives

Study type: Interventional

Funder types: Other

Identifiers

NCT02073136

H-1-2013-106

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Phosphate modified diet

Experimental group

Treatment:

Other: Diet with phosphate containing additives

Other: Diet without phosphate containing additives