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

NCT02073136 | Completed

• 1 other identifier: H-1-2013-106
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Phosphate balance

  1 week

Secondary Outcomes (7)

• p-phosphate

  1 week

• p-PTH

  1 week

• p-Calcium

  1 week

• FGF23

  1 week

• p-25(OH)D

  1 week

Study Arms (1)

Phosphate modified diet

EXPERIMENTAL

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

Interventions

Diet with phosphate containing additives OTHER

Phosphate modified diet

Diet without phosphate containing additives OTHER

Phosphate modified diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• Camilla Storm Slumstrup: collaborator
• Ewa Lewin: collaborator
• Casper Rydahl: collaborator

Study Sites (1)

Herlev Hospital

Herlev, Herlev Ringvej 75, 2730, Denmark

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Diet

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jens R Andersen, MD, MPA

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor at the University of Copenhagen

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: February 27, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 18, 2014

Record last verified: 2014-07

Locations

DK (1)