Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5

NCT05970094 | Completed DMC

• 1 other identifier: H-21069570
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about and test the effect of an acid/base diet, in chronic kidney patients with CKD stage 4 and 5 in an interventional study with a historical control. The hypothesize is, that an acid/base diet will reduce the degree of acidosis and the need for oral bicarbonate supplements.

Conditions

Kidney Diseases; Metabolic Acidosis; Renal Insufficiency; CKD; Pre-dialysis

Keywords

Potential renal acid load; PRAL; Study design; Diet; Humans; Elderly; Bicarbonate/blood; Muscle strength; Hand strength; Chair stand test; Calorimetry, indirect; Bone mineralization; Carbon dioxide/blood; Phosphor/urine; Potassium/urine; Urea/blood; Urea/urine

Outcome Measures

Primary Outcomes (1)

• Plasma-total CO2

  mmol/l

  6 weeks

Secondary Outcomes (19)

• Plasma-alkaline phosphatase

  6 weeks

• Plasma-sodium ion

  6 weeks

• Plasma-creatinine

  6 weeks

• Plasma-parathyroid hormone

  6 weeks

• Plasma-carbamide

  6 weeks

Other Outcomes (4)

• Plasma-Potassium

  6 weeks

• Plasma-calcium

  6 weeks

• Plasma-magnesium

  6 weeks

Study Arms (1)

Low PRAL diet

EXPERIMENTAL

Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up).

Other: Low PRAL

Interventions

Low PRAL OTHER

Two weeks on a low PRAL diet compared to 2 week free living

Low PRAL diet

Eligibility Criteria

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

You may qualify if:

• Chronic acidosis (plasma-bicarbonat under 22 mmol/l at multiple measures within the last 12 months).
• Diagnosed with non-dialysis needed chronic kidney disease in stage 4 and 5 (eGFR below 30 ml/min/1,73 m2)
• Of legal age and over 18 of years
• Understand danish and understand the written material
• Able to cooperate about the diet
• Able to take pictures with their phone or willing to learn

You may not qualify if:

• Vegan and vegetarian with very low intake of animal protein (below 25 g/day)
• Pregnant or breast feeding
• Patients with short bowel syndrome, brickre's bladder, pancreatitis or any other known malabsorption problem
• Potassium above 5 mmol/l
• Ongoing infection

Sponsors & Collaborators

• University of Copenhagen: lead
• Nordsjaellands Hospital: collaborator

Study Sites (1)

Nordshjaellands Hospital

Hillerød, 3400, Denmark

Location

MeSH Terms

Conditions

Kidney Diseases; Acidosis; Renal Insufficiency

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jens Rikardt Andersen, MD, MPA

  University of Copenhagen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up).

Study Record Dates

• First Submitted: July 23, 2023
• First Posted: August 1, 2023
• Study Start: March 6, 2023
• Primary Completion: August 20, 2023
• Study Completion: November 20, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)