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

Primary Purpose

Chronic Kidney Disease, Stage 3 (Moderate)

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
New Nordic Renal Diet
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Disease, Stage 3 (Moderate)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

- Intake of phosphate binders

Sites / Locations

  • Arne V. Astrup

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Habitual diet

New Nordic Renal Diet

Arm Description

18 participants were on a habitual diet for 7 days

18 participants were given a New Nordic Renal Diet for 7 days

Outcomes

Primary Outcome Measures

24-hour urine phosphorus excretion
primary outcome was measured by 24-hour urine collection

Secondary Outcome Measures

Full Information

First Posted
March 13, 2018
Last Updated
November 11, 2019
Sponsor
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT03472105
Brief Title
Short-term Effect of a New Nordic Renal Diet on Phosphorus Homeostasis in CKD Stage 3-4
Official Title
Short-term Effect of a New Nordic Renal Diet on Phosphorus Homeostasis in CKD Stage 3-4
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
November 6, 2017 (Actual)
Study Completion Date
November 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Stage 3 (Moderate)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Habitual diet
Arm Type
Other
Arm Description
18 participants were on a habitual diet for 7 days
Arm Title
New Nordic Renal Diet
Arm Type
Active Comparator
Arm Description
18 participants were given a New Nordic Renal Diet for 7 days
Intervention Type
Dietary Supplement
Intervention Name(s)
New Nordic Renal Diet
Other Intervention Name(s)
Habitual Diet
Intervention Description
One week ingesting a phosphorus reduced diet containing a total of 850 mg of phosphorus/day compared to one week of a habitual diet
Primary Outcome Measure Information:
Title
24-hour urine phosphorus excretion
Description
primary outcome was measured by 24-hour urine collection
Time Frame
7 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: - Intake of phosphate binders
Facility Information:
Facility Name
Arne V. Astrup
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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

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