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Chronic Kidney Disease, Stage 3 (Moderate)NCT03472105

Short-term Effect of a New Nordic Renal Diet on Phosphorus Homeostasis in CKD Stage 3-4

A study testing New Nordic Renal Diet in people with Chronic Kidney Disease, Stage 3 (Moderate), run by University of Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hyperphosphatemia is a severe complication to chronic kidney disease (CKD) and is associated with increased risk of vascular calcification, cardiovascular morbidity and mortality. Early dietary intervention and improvement in dietary therapy might optimally reduce cardiovascular complications. Read more about this study

Who is it for?
Any age
What is being tested?
New Nordic Renal Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteDenmark
Study dates
1 Feb 2017to 6 Nov 2017
Phase
Interventional
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Estimated glomerular filtration rate (eGFR) 16 to 45 ml/min/1.73 m2, as judged by CKD-EPI equation
  • Medically stable for 2 months before and during the study
  • No food allergies
  • Ability to understand the Danish language orally and in writing

Who cannot join

  • Intake of phosphate binders

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Arne V. Astrup

    Copenhagen

Other trials in Denmark

About this study

Hyperphosphatemia is a severe complication to chronic kidney disease (CKD) and is associated with increased risk of vascular calcification, cardiovascular morbidity and mortality. Early dietary intervention and improvement in dietary therapy might optimally reduce cardiovascular complications. For this purpose the investigators investigated patients with CKD stage 3-4, the participants dietary habits, developed a New Nordic Renal Diet and investigated the short term effect on phosphorus homeostasis.

Read the detailed description

Development of the New Nordic Renal Diet The NND was not suitable for CKD patients in its present form because of too high phosphorus content. By going through the diet composition in details and reducing some of the phosphorus rich food items such as nuts, dairy products, rye bread and fish and reducing the daily intake of meat to a total of 120 mg/day we designed the NNRD with a total of 850 mg phosphorus per day and 0.8 g protein per kg per day. Two main principles were important; affordable and palatable.

Phosphorus content of the meals The nutrient content of the meals were based on information from the Danish food composition data bank; Dankost 3000® (version 7.01, 2009, Dankost, Copenhagen, Denmark). The diets during the intervention were designed to be iso-caloric. The phosphorus content in the samples was determined by inductively coupled plasma mass spectrometry (ICPMS) at the National Food Institute at the Technical University of Denmark. Briefly, the samples were lyophilized and homogenized to a fine powder. Subsamples (0.3 g) were digested with concentrated nitric acid in a microwave oven (Multiwave 3000, Anton Paar, Graz, Austria). The quantification of phosphorus (31P) was done with external calibration using 45Sc as internal standard. The ICPMS (Thermo iCAPq, Bremen, Germany) was run in KED mode using helium as cell gas. For quality assurance of the results, the certified reference material BCR63R (Skim milk powder) was analyzed and the obtained results (10.9+/-0.3 mg/g) were in good agreement with the certified target value (11.1+/-0.13 mg/g).

Study Nineteen patients were recruited from the outpatient clinic at the Department of Nephrology, Copenhagen University, Rigshospitalet and 1 patient from Department of Nephrology, Copenhagen University, Herlev Hospital.

This was a randomized controlled crossover study of two diets in patients with CKD stage 3-4 (figure 1). Baseline data (day 0) was obtained including 24-h urine collection, fasting blood samples and dietary record. During the intervention the participants received our phosphorus reduced version of the NND termed the NNRD for 1 week, fasting blood samples was achieved on day 1 and 4 together with 24-hour urine collection. During the control period the participants kept to their habitual diet from day 1 - 6 (on day 1 and day 4, they kept a dietary record and collected 24-h urine) and on day 7 they received a control diet with a phosphorus content in accordance with an average Danish diet (1500 mg). On day 7, in both the two intervention periods, the patients were admitted to the Department of Nephrology, University Hospital of Copenhagen, Rigshospitalet to follow the circadian rhythm of plasma phosphate, plasma intact FGF23, plasma calcium and plasma PTH. Fasting blood sample and 24-h urine collection was obtained, and blood was additionally drawn 30 min after each of the three meals.

During the NNRD intervention there were two daily meals, given with a two-day rotation. Diet planning and analysis was initially done using the Food Composition Data bank (version 7.01, 2009, Copenhagen, Denmark). The actual measured phosphorus content was equal to the calculated value from the Food Composition Data bank and the diets were kept unchanged.

Self-reporting questionnaire The dietary compliance, satisfaction and satiation were judged by written self-reported questionnaire during the NNRD (supplemental material). Dietary satisfaction was judged by a five-level Likert scale with following response options: very good, good, okay, not good and bad. A similar method was used for the dietary compliance with the following response options: 100%, 80%, 60%, 40% and 20%. The satiation was judged by yes or no.

Being tested
New Nordic Renal Diet
Medical subject headings
Renal Insufficiency, Chronic, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • New Nordic Renal DietDietary supplement

    Also called Habitual Diet

    One week ingesting a phosphorus reduced diet containing a total of 850 mg of phosphorus/day compared to one week of a habitual diet

Study groups in NCT03472105
Study groupRoleWhat they receive
Habitual dietOther18 participants were on a habitual diet for 7 days
Receives: Dietary Supplement: New Nordic Renal Diet
New Nordic Renal DietActive comparator18 participants were given a New Nordic Renal Diet for 7 days
Receives: Dietary Supplement: New Nordic Renal Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 24-hour urine phosphorus excretion

    primary outcome was measured by 24-hour urine collection

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2018
  2. Study start1 Feb 2017
  3. Primary completion6 Nov 2017
  4. Study completion6 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Model description
The aim of this study was to investigate if 7 days of dietary intake of New Nordic Renal Diet reduces the 24-hour urinary phosphorus excretion and other components of the phosphorus homeostasis in 18 moderate CKD patients compared to 7 days of habitual diet.
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03472105
Sponsor's protocol ID
H-16033940
Status last verified
Nov 2019
First submitted
13 Mar 2018
Last updated
13 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing New Nordic Renal Diet in people with Chronic Kidney Disease, Stage 3 (Moderate), run by University of Copenhagen at 1 site 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 4 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: finished, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24-hour urine phosphorus excretion (time frame: 7 days). 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 13 Nov 2019.

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