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

NCT03472105 | Completed

• 1 other identifier: H-16033940
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease, Stage 3 (Moderate)

Outcome Measures

Primary Outcomes (1)

• 24-hour urine phosphorus excretion

  primary outcome was measured by 24-hour urine collection

  7 days

Study Arms (2)

Habitual diet

OTHER

18 participants were on a habitual diet for 7 days

Dietary Supplement: New Nordic Renal Diet

New Nordic Renal Diet

ACTIVE COMPARATOR

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

Dietary Supplement: New Nordic Renal Diet

Interventions

New Nordic Renal Diet DIETARY_SUPPLEMENT

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

Also known as: Habitual Diet

Habitual diet; New Nordic Renal Diet

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Intake of phosphate binders

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Arne V. Astrup

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 21, 2018
• Study Start: February 1, 2017
• Primary Completion: November 6, 2017
• Study Completion: November 6, 2017
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)