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

July 17, 2014 updated by: Jens Rikardt Andersen, University of Copenhagen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Herlev Ringvej 75
      • Herlev, Herlev Ringvej 75, Denmark, 2730
        • Herlev Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phosphate modified diet
Other: Diet with phosphate containing additives
Other: Diet without phosphate containing additives

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phosphate balance
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
p-phosphate
Time Frame: 1 week
1 week
p-PTH
Time Frame: 1 week
1 week
p-Calcium
Time Frame: 1 week
1 week
FGF23
Time Frame: 1 week
1 week
p-25(OH)D
Time Frame: 1 week
1 week
Calcium-phosphate product
Time Frame: 1 week
1 week
p-alkaline phosphatase
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Camilla Storm Slumstrup
Ewa Lewin
Casper Rydahl

Investigators

  • Principal Investigator: Jens R Andersen, MD, MPA, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

February 25, 2014

First Submitted That Met QC Criteria

February 26, 2014

First Posted (Estimate)

February 27, 2014

Study Record Updates

Last Update Posted (Estimate)

July 18, 2014

Last Update Submitted That Met QC Criteria

July 17, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1-2013-106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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