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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02073136
Enrollment
24
Registered
2014-02-27
Start date
2014-03-31
Completion date
2014-07-31
Last updated
2014-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

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.

Interventions

OTHERDiet with phosphate containing additives
OTHERDiet without phosphate containing additives

Sponsors

Camilla Storm Slumstrup
CollaboratorUNKNOWN
Ewa Lewin
CollaboratorUNKNOWN
Casper Rydahl
CollaboratorUNKNOWN
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frame
Phosphate balance1 week

Secondary

MeasureTime frame
p-PTH1 week
p-Calcium1 week
FGF231 week
p-phosphate1 week
Calcium-phosphate product1 week
p-alkaline phosphatase1 week
p-25(OH)D1 week

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026