CKDNCT07312981
The CPH-MBD Cohort Dietary Substudy - Comparison of Methods for Dietary Registrations
An observational study of CKD and Renal Insufficiency Chronic, run by University of Copenhagen at 2 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CKD, Renal Insufficiency Chronic, CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder
- How many people
- 50 participants
- Where
- 2 sitesDenmark
- Study dates
- 15 Dec 2025to 15 May 2029
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic kidney disease stage 4-5
Who may be able to join
- A glomerular filtration rate of <30 ml ml/min/1.73m2
- 18 years and above
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 1 recruiting
- Active, not recruiting
Copenhagen University Hospital - Herlev
Herlev, Capital Region, 2730
- Recruiting
Herlev Hospital, Dept Nephrology
Herlev, 2730
Julian Askøe Bluming, RD, 004591568528, lft190@alumni.ku.dk
Julian A Bluming, RD
About this study
Official title: 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
Read the 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.
- Conditions
- CKD, Renal Insufficiency Chronic, CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder, Pre-dialysis
- Keywords
- Diet, Humans, Observational, Cohort, Phosphate/urine, Calcium/urine, Mineral bone disorder, Elderly, Calcium Balance, Phosphate Balance
- Medical subject headings
- Renal Insufficiency, Chronic, Chronic Kidney Disease-Mineral and Bone Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of diatery photograph method with weighted records.
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.
Measured: 3 days
Calcium and phosphate balance in relation to the stage of kidney disease
Measured by the diatery intake of calcium and phosphate in relation to the urinary calcium and phosphate excretion
Measured: 3 days
Secondary outcomes (20)
Urinary Calcium
mmol/day
Measured: 3 days
Urinary phosphate
mmol/day
Measured: 3 days
Calcium intake total and the distribution of vegetarian and animal sources
mg/day
Measured: 3 days
Phosphate intake total and the distribution of vegetarian and animal sources
mg/day
Measured: 3 days
sodium intake total and the distribution of vegetarian and animal sources
mg/day
Measured: 3 days
Energy intake
Kcal/day
Measured: 3 days
Protein intake
g/day
Measured: 3 days
Fat intake
g/day
Measured: 3 days
Fluid intake
ml/day
Measured: 3 days
Plasma phosphate
mmol/l
Measured: 3 days
Plasma calcium
mmol/l
Measured: 3 days
Urinary creatinine
mmol/day
Measured: 3 days
Urinary urea
mmol/day
Measured: 3 days
Urinary sodium
mmol/day
Measured: 3 days
Plasma FGF23
mmol/l
Measured: 3 days
P-calcium P- phosphate product
Can be calculated by multiplying plasma calcium and plasma phosphate
Measured: 3 days
plasma 25-OH-Vitamin D
nmol/l
Measured: 3 days
plasma PTH
pmol/l
Measured: 3 days
Plasma Albumin
g/dl
Measured: 3 days
eGFR
ml/min/1.73m2
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start15 Dec 2025
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital
- Responsible party
- Sponsor
- Investigators
- Jens Rikardt Andersen, MD, MPA, Assoc Prof, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312981
- Sponsor's protocol ID
- H-25039131
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently no plans for sharing
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CPH-MBD Cohort - Substudy on Dietary History
- ClinicalTrials.gov ID
- NCT07312981
- Acronym / sponsor ID
- H-25039131
- Conditions
- CKD, Renal Insufficiency Chronic, CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder, Pre-dialysis
- Keywords
- Diet, Humans, Observational, Cohort, Phosphate/urine, Calcium/urine, Mineral bone disorder, Elderly
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Herlev Hospital
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2029 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic kidney disease stage 4-5
Key inclusion criteria (2 listed)
- A glomerular filtration rate of <30 ml ml/min/1.73m2
- 18 years and above
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
20 secondary outcomes
Urinary Calcium
Time frame: 3 days
Urinary phosphate
Time frame: 3 days
Calcium intake total and the distribution of vegetarian and animal sources
Time frame: 3 days
Phosphate intake total and the distribution of vegetarian and animal sources
Time frame: 3 days
sodium intake total and the distribution of vegetarian and animal sources
Time frame: 3 days
Energy intake
Time frame: 3 days
Protein intake
Time frame: 3 days
Fat intake
Time frame: 3 days
Fluid intake
Time frame: 3 days
Plasma phosphate
Time frame: 3 days
Plasma calcium
Time frame: 3 days
Urinary creatinine
Time frame: 3 days
Urinary urea
Time frame: 3 days
Urinary sodium
Time frame: 3 days
Plasma FGF23
Time frame: 3 days
P-calcium P- phosphate product
Time frame: 3 days
plasma 25-OH-Vitamin D
Time frame: 3 days
plasma PTH
Time frame: 3 days
Plasma Albumin
Time frame: 3 days
eGFR
Time frame: 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: No. Currently no plans for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jens Rikardt Andersen, MD, MPA, Assoc Prof principal investigator
University of Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CKD and Renal Insufficiency Chronic, run by University of Copenhagen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jens Rikardt Andersen, MD, MPA (004523346654, jra@nexs.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of diatery photograph method with weighted records. (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.