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Completed

NCT Number: NCT03868371

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

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.

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Key information

Conditions

Chronic Kidney Disease Stage 5 Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Mineral Metabolism Disorder Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herlev Hospital

Herlev, 2730, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High phosphorous containing meal

Dietary Supplement

A meal with a high phosphorous content

Low phosphorous containing meal

Dietary Supplement

A meal with a low phosphorous content

Primary outcomes

  1. Difference in plasma phosphate in mmol/L at 5 specific times following a high-phosphate containing meal compared to a low-phosphate containing meal measured by analyzing of blood samples at each specific time.

    Time frame: 5 hours

    The specific times are: Before consumption of the meal(time 0), and 1 hour, 2 hours, 3 hours and 5 hours after consumption of the meal.

Secondary outcomes

  1. Changes in plasma phosphate in mmol/L in blood samples at 5 specific times following a high-phosphate meal or low-phosphate meal compared to levels of plasma phosphate at preceding specific times and differences in these changes.

    Time frame: 5 hours

    The specific times are: Before consumption of the meal(time 0), and 1 hour, 2 hours, 3 hours and 5 hours after consumption of the meal.

  2. Difference in serum ionized calcium at 5 specific times following a high-phosphate containing meal compared to a low-phosphate containing meal measured by analyzing of blood samples at each specific time.

    Time frame: 5 hours

    The specific times are: Before consumption of the meal(time 0), and 1 hour, 2 hours, 3 hours and 5 hours after consumption of the meal.

  3. Changes in serum ionized calcium in blood samples at 5 specific times following a high-phosphate meal or low-phosphate meal compared to levels of serum ionized calcium at preceding specific times and differences in these changes.

    Time frame: 5 hours

    The specific times are: Before consumption of the meal(time 0), and 1 hour, 2 hours, 3 hours and 5 hours after consumption of the meal.

  4. Difference in plasma PTH at 5 specific times following a high-phosphate containing meal compared to a low-phosphate containing meal measured by analyzing of blood samples at each specific time.

    Time frame: 5 hours

    The specific times are: Before consumption of the meal(time 0), and 1 hour, 2 hours, 3 hours and 5 hours after consumption of the meal.

  5. Changes in plasma PTH in blood samples at 5 specific times following a high-phosphate meal or low-phosphate meal compared to levels of plasma PTH at preceding specific times and differences in these changes.

    Time frame: 5 hours

    The specific times are: Before consumption of the meal(time 0), and 1 hour, 2 hours, 3 hours and 5 hours after consumption of the meal.

  6. Difference in plasma FGF-23 at 5 specific times following a high-phosphate containing meal compared to a low-phosphate containing meal measured by analyzing of blood samples at each specific time.

    Time frame: 5 hours

    The specific times are: Before consumption of the meal(time 0), and 1 hour, 2 hours, 3 hours and 5 hours after consumption of the meal.

  7. Changes in plasma FGF-23 in blood samples at 5 specific times following a high-phosphate meal or low-phosphate meal compared to levels of plasma FGF-23 at preceding specific times and differences in these changes.

    Time frame: 5 hours

    The specific times are: Before consumption of the meal(time 0), and 1 hour, 2 hours, 3 hours and 5 hours after consumption of the meal.

  8. Difference in plasma magnesium at 5 specific times following a high-phosphate containing meal compared to a low-phosphate containing meal measured by analyzing of blood samples at each specific time.

    Time frame: 5 hours

    The specific times are: Before consumption of the meal(time 0), and 1 hour, 2 hours, 3 hours and 5 hours after consumption of the meal.

  9. Changes in plasma magnesium in blood samples at 5 specific times following a high-phosphate meal or low-phosphate meal compared to levels of plasma magnesium at preceding specific times and differences in these changes.

    Time frame: 5 hours

    The specific times are: Before consumption of the meal(time 0), and 1 hour, 2 hours, 3 hours and 5 hours after consumption of the meal.

  10. Difference in plasma 1,25(OH)2 Vitamin D at 5 specific times following a high-phosphate containing meal compared to a low-phosphate containing meal measured by analyzing of blood samples at each specific time.

    Time frame: 5 hours

    The specific times are: Before consumption of the meal(time 0), and 1 hour, 2 hours, 3 hours and 5 hours after consumption of the meal.

  11. Changes in plasma 1,25(OH)2 Vitamin D in blood samples at 5 specific times following a high-phosphate meal or low-phosphate meal compared to levels of plasma 1,25(OH)2 Vitamin D at preceding specific times and differences in these changes.

    Time frame: 5 hours

    The specific times are: Before consumption of the meal(time 0), and 1 hour, 2 hours, 3 hours and 5 hours after consumption of the meal.

  12. Difference in T50 at 5 specific times following a high-phosphate containing meal compared to a low-phosphate containing meal measured by analyzing of blood samples at each specific time.

    Time frame: 5 hours

    The specific times are: Before consumption of the meal(time 0), and 1 hour, 2 hours, 3 hours and 5 hours after consumption of the meal.

  13. Changes in T50 in blood samples at 5 specific times following a high-phosphate meal or low-phosphate meal compared to levels of T50 at preceding specific times and differences in these changes.

    Time frame: 5 hours

    The specific times are: Before consumption of the meal(time 0), and 1 hour, 2 hours, 3 hours and 5 hours after consumption of the meal.

  14. Differences in levels between the groups of serum ionized calcium, plasma PTH, plasma FGF-23, plasma magnesium, plasma 1,25(OH)2 Vitamin D, T50 and plasma phosphate at specific times following either a high phosphate or low phosphate containing meal.

    Time frame: 5 hours

    The specific times are: Before consumption of the meal(time 0), and 1 hour, 2 hours, 3 hours and 5 hours after consumption of the meal.

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Official study title

Acute Changes in the Mineral Metabolism After a High Phosphorous Containing Meal in Dialysis Patients - a Randomized Cross-over Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 11, 2019
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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