NCT03868371

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

March 5, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

5 months

First QC Date

March 4, 2019

Last Update Submit

August 13, 2019

Conditions

Chronic Kidney Disease Stage 5Mineral Metabolism Disorder

Outcome Measures

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.

    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 hours

Secondary Outcomes (14)

  • 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.

    5 hours

  • 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.

    5 hours

  • 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.

    5 hours

  • 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.

    5 hours

  • 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.

    5 hours

  • +9 more secondary outcomes

Study Arms (2)

1. high - 2. low

ACTIVE COMPARATOR

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 mealDietary Supplement: Low phosphorous containing meal

1. low - 2. high

ACTIVE COMPARATOR

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 mealDietary Supplement: Low phosphorous containing meal

Interventions

High phosphorous containing mealDIETARY_SUPPLEMENT

A meal with a high phosphorous content

1. high - 2. low1. low - 2. high
Low phosphorous containing mealDIETARY_SUPPLEMENT

A meal with a low phosphorous content

1. high - 2. low1. low - 2. high

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ditte Hansen, PhD

    Herlev Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 11, 2019

Study Start

March 5, 2019

Primary Completion

August 13, 2019

Study Completion

August 13, 2019

Last Updated

August 14, 2019

Record last verified: 2019-08

Locations

DK(1)