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Recruiting NCT07312981

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

Observational CKD Renal Insufficiency Chronic CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder Pre-dialysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: CKD, Renal Insufficiency Chronic, CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder, Pre-dialysis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The CPH-MBD Cohort - Substudy on Dietary History

Overview

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.

Primary outcome measures

  • Comparison of diatery photograph method with weighted records. [Time frame: 3 days]
  • Calcium and phosphate balance in relation to the stage of kidney disease [Time frame: 3 days]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Denmark · 2 centers
  • Copenhagen University Hospital - Herlev — Herlev
  • Herlev Hospital, Dept Nephrology — Herlev

Identifiers

NCT: NCT07312981 · H-25039131

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗