The CPH-MBD Cohort Dietary Substudy - Comparison of Methods for Dietary Registrations

December 17, 2025 updated by: University of Copenhagen

The CPH-MBD Cohort - Substudy on Dietary History

The aim of the study is to assess the association between the calcium and phosphorus balance and the stage of kidney disease measured by creatinine clearence in patients with chronic kidney disease stage 4 and 5. The balance is measured a measurement between the recorded diatery intake and the urinary excretion. Additionally a comparison between image based diatery accessment and weighted records will be measured

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

All participants will be asked to take photos of all the food and fluids they consume during 24 hours. Additionally participants will be offered to weight their food and fluid for 3 days.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jens Rikardt Andersen, MD, MPA
  • Phone Number: 004523346654
  • Email: jra@nexs.ku.dk

Study Contact Backup

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Recruiting
        • Herlev Hospital, Dept Nephrology
        • Contact:
        • Sub-Investigator:
          • Julian A Bluming, RD
    • Capital Region
      • Herlev, Capital Region, Denmark, 2730
        • Active, not recruiting
        • Copenhagen University Hospital - Herlev

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic kidney disease stage 4-5

Description

Inclusion Criteria:

  • A glomerular filtration rate of <30 ml ml/min/1.73m2
  • 18 years and above

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison of diatery photograph method with weighted records.
Time Frame: 3 days
The intake of calcium and phosphate assesed by the 24 hour photos and the 72 hour weighing of food and fluid items will be compared.
3 days
Calcium and phosphate balance in relation to the stage of kidney disease
Time Frame: 3 days
Measured by the diatery intake of calcium and phosphate in relation to the urinary calcium and phosphate excretion
3 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Urinary Calcium
Time Frame: 3 days
mmol/day
3 days
Urinary phosphate
Time Frame: 3 days
mmol/day
3 days
Calcium intake total and the distribution of vegetarian and animal sources
Time Frame: 3 days
mg/day
3 days
Phosphate intake total and the distribution of vegetarian and animal sources
Time Frame: 3 days
mg/day
3 days
sodium intake total and the distribution of vegetarian and animal sources
Time Frame: 3 days
mg/day
3 days
Energy intake
Time Frame: 3 days
Kcal/day
3 days
Protein intake
Time Frame: 3 days
g/day
3 days
Fat intake
Time Frame: 3 days
g/day
3 days
Fluid intake
Time Frame: 3 days
ml/day
3 days
Plasma phosphate
Time Frame: 3 days
mmol/l
3 days
Plasma calcium
Time Frame: 3 days
mmol/l
3 days
Urinary creatinine
Time Frame: 3 days
mmol/day
3 days
Urinary urea
Time Frame: 3 days
mmol/day
3 days
Urinary sodium
Time Frame: 3 days
mmol/day
3 days
Plasma FGF23
Time Frame: 3 days
mmol/l
3 days
P-calcium P- phosphate product
Time Frame: 3 days
Can be calculated by multiplying plasma calcium and plasma phosphate
3 days
plasma 25-OH-Vitamin D
Time Frame: 3 days
nmol/l
3 days
plasma PTH
Time Frame: 3 days
pmol/l
3 days
Plasma Albumin
Time Frame: 3 days
g/dl
3 days
eGFR
Time Frame: 3 days
ml/min/1.73m2
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Copenhagen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Herlev Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jens Rikardt Andersen, MD, MPA, Assoc Prof, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-25039131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Currently no plans for sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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