Skip to main content
OpenTrials
Completed

NCT Number: NCT02073136

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet with phosphate containing additives

Other

Diet without phosphate containing additives

Other

Primary outcomes

  1. Phosphate balance

    Time frame: 1 week

Secondary outcomes

  1. p-phosphate

    Time frame: 1 week

  2. p-PTH

    Time frame: 1 week

  3. p-Calcium

    Time frame: 1 week

  4. FGF23

    Time frame: 1 week

  5. p-25(OH)D

    Time frame: 1 week

  6. Calcium-phosphate product

    Time frame: 1 week

  7. p-alkaline phosphatase

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Camilla Storm Slumstrup
  • Casper Rydahl
  • Ewa Lewin

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 27, 2014
Registry last updated
Jul 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.