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.
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
- Conditions the study is for
- Chronic Kidney Disease, Stage 3 (Moderate)
- 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.
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 group | Role | What they receive |
|---|---|---|
| Habitual diet | Other | 18 participants were on a habitual diet for 7 days Receives: Dietary Supplement: New Nordic Renal Diet |
| New Nordic Renal Diet | Active comparator | 18 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.
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.
- First posted21 Mar 2018
- Study start1 Feb 2017
- Primary completion6 Nov 2017
- Study completion6 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease, Stage 3 (Moderate)Studies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- 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)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effect of a New Nordic Renal Diet on Phosphorus Homeostasis in CKD Stage 3-4
- ClinicalTrials.gov ID
- NCT03472105
- Acronym / sponsor ID
- H-16033940
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 6 Nov 2017 (actual)
- Study completion
- 6 Nov 2017 (actual)
- First posted
- 21 Mar 2018 (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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Habitual diet | Other | Dietary Supplement: New Nordic Renal Diet18 participants were on a habitual diet for 7 days |
| New Nordic Renal Diet | Active comparator | Dietary Supplement: New Nordic Renal Diet18 participants were given a New Nordic Renal Diet for 7 days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Intake of phosphate binders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New Nordic Renal DietAlso: Habitual DietOne week ingesting a phosphorus reduced diet containing a total of 850 mg of phosphorus/day compared to one week of a habitual diet | Dietary supplement | Habitual diet, New Nordic Renal Diet |
Primary outcome
24-hour urine phosphorus excretion
Time frame: 7 days
primary outcome was measured by 24-hour urine collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.