Acute Changes in the Mineral Metabolism After a High Phosphorous Containing Meal in Dialysis Patients

Herlev Hospital

Status: Completed

Conditions: Mineral Metabolism Disorder; Chronic Kidney Disease Stage 5

Treatments: Dietary Supplement: High phosphorous containing meal; Dietary Supplement: Low phosphorous containing meal

Study type: Interventional

Funder types: Other

Identifiers

NCT03868371

H-18063465

Details and patient eligibility

About

The purpose of the study is to investigate whether a high phosphorous containing meal causes acute changes in p-phosphate levels in patients with dialysis-dependent kidney failure.

Full description

Disturbances in the mineral metabolism and especially the phosphate metabolism is associated with increased risk of cardiovascular disease and death in patients with kidney failure. In the healthy population the kidney compensates for a high phosphorous intake by increase renal excretion of phosphate, but this is not possible for patients with kidney failure. Due to this monitoring and controlling phosphate levels is an important clinical goal in treatment of kidney failure, and it is often achieved with a phosphorous poor diet and phosphate binders.

Currently this monitoring of the phosphate level is complicated by a poor understanding of how plasma phosphate acutely reacts to a phosphate rich meal. Often patients may have consumed a phosphate rich meal shortly before their blood test is taken, which may have an acute impact on the plasma phosphate level in the blood test and complicated the task of assessing their chronic phosphate levels.

To examine this problem, the investigators wish to conduct a randomized cross-over trial, where peritoneal dialysis patients are recruited and randomly assigned to consume either a meal either high or low in phosphate on the first day of trial and the opposite in the second.

With blood tests just before and during 5 hours after the meal, the investigators will examine plasma-phosphate levels as well as other blood parameters of importance to the mineral metabolism to determine, whether a meal rich in phosphate causes significant changes in these test parameters compared to a meal poor in phosphate.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years of age
• Currently treated with peritoneal dialysis (APD or CAPD)
• Serum ionized calcium between 1.10 and 1.40 mmol/L for >3 months
• Plasma phosphate between 0.7 and 3.0 mmol/L for >3 months

Exclusion criteria

• Earlier parathyroidectomized
• Other conditions, which hinders the participation in the trial

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 2 patient groups

1. high - 2. low

Active Comparator group

Description:

These are the patients receiving a high phosphorous containing meal in the first trial day, and a low phosphorous containing meal in the second trial day.

Treatment:

Dietary Supplement: High phosphorous containing meal

Dietary Supplement: Low phosphorous containing meal

1. low - 2. high

Active Comparator group

Description:

These are the patients receiving a low phosphorous containing meal in the first trial day, and a high phosphorous containing meal in the second trial day.

Treatment:

Dietary Supplement: High phosphorous containing meal

Dietary Supplement: Low phosphorous containing meal