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CompletedNCT02073136Updated Jul 18, 2014

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

An interventional study of Diet with phosphate containing additives and Diet without phosphate containing additives in Chronic Kidney Disease, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-18.

Sponsored by University of Copenhagen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Kidney Disease
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 24 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Phosphate modified diet

    Other: Diet with phosphate containing additives · Other: Diet without phosphate containing additives

Interventions

  • OtherDiet with phosphate containing additives
  • OtherDiet without phosphate containing additives
06

What researchers measure

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

07

Study locations

1 site
  • Herlev Hospital
    Herlev, Herlev Ringvej 75 2730, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02073136
Lead sponsor
University of Copenhagen
Collaborators
Camilla Storm Slumstrup, Ewa Lewin, Casper Rydahl
Responsible party
Jens Rikardt Andersen (Associate professor at the University of Copenhagen, University of Copenhagen) — Principal investigator
First posted
Feb 27, 2014
Start date
Mar 2014
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Jul 18, 2014

Study contacts

Jens R Andersen, MD, MPA
principal investigator · University of Copenhagen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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