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Trial record 72 of 108 for:    CALCIUM CATION

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

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ClinicalTrials.gov Identifier: NCT03868371
Recruitment Status : Completed
First Posted : March 11, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Ditte Hansen, Herlev Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Stage 5 Mineral Metabolism Disorder Dietary Supplement: High phosphorous containing meal Dietary Supplement: Low phosphorous containing meal Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Acute Changes in the Mineral Metabolism After a High Phosphorous Containing Meal in Dialysis Patients - a Randomized Cross-over Trial
Actual Study Start Date : March 5, 2019
Actual Primary Completion Date : August 13, 2019
Actual Study Completion Date : August 13, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Minerals
Drug Information available for: Phosphorus

Arm Intervention/treatment
Active Comparator: 1. high - 2. low
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.
Dietary Supplement: High phosphorous containing meal
A meal with a high phosphorous content

Dietary Supplement: Low phosphorous containing meal
A meal with a low phosphorous content

Active Comparator: 1. low - 2. high
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.
Dietary Supplement: High phosphorous containing meal
A meal with a high phosphorous content

Dietary Supplement: Low phosphorous containing meal
A meal with a low phosphorous content




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868371


Locations
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Denmark
Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Investigators
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Principal Investigator: Ditte Hansen, PhD Herlev Hospital

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Responsible Party: Ditte Hansen, Associate professor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT03868371     History of Changes
Other Study ID Numbers: H-18063465
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Metabolic Diseases
Urologic Diseases
Renal Insufficiency