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

Primary Purpose

Chronic Kidney Disease Stage 5, Mineral Metabolism Disorder

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
High phosphorous containing meal
Low phosphorous containing meal
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Disease Stage 5

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Herlev Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1. high - 2. low

1. low - 2. high

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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 Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 4, 2019
Last Updated
August 13, 2019
Sponsor
Herlev Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03868371
Brief Title
Acute Changes in the Mineral Metabolism After a High Phosphorous Containing Meal in Dialysis Patients
Official Title
Acute Changes in the Mineral Metabolism After a High Phosphorous Containing Meal in Dialysis Patients - a Randomized Cross-over Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 5, 2019 (Actual)
Primary Completion Date
August 13, 2019 (Actual)
Study Completion Date
August 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Stage 5, Mineral Metabolism Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. high - 2. low
Arm Type
Active Comparator
Arm 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.
Arm Title
1. low - 2. high
Arm Type
Active Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
High phosphorous containing meal
Intervention Description
A meal with a high phosphorous content
Intervention Type
Dietary Supplement
Intervention Name(s)
Low phosphorous containing meal
Intervention Description
A meal with a low phosphorous content
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
5 hours
Title
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.
Description
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.
Time Frame
5 hours
Title
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.
Description
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.
Time Frame
5 hours
Title
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.
Description
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.
Time Frame
5 hours
Title
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.
Description
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.
Time Frame
5 hours
Title
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.
Description
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.
Time Frame
5 hours
Title
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.
Description
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.
Time Frame
5 hours
Title
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.
Description
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.
Time Frame
5 hours
Title
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.
Description
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.
Time Frame
5 hours
Title
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.
Description
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.
Time Frame
5 hours
Title
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.
Description
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.
Time Frame
5 hours
Title
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.
Description
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.
Time Frame
5 hours
Title
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.
Description
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.
Time Frame
5 hours
Title
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.
Description
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.
Time Frame
5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ditte Hansen, PhD
Organizational Affiliation
Herlev Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

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

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