NCT05784389

Brief Summary

This clinical trial aims to investigate and test the effect of an acid/base diet in chronic kidney disease (CKD) patients, CKD stage 4 and 5. The trial is guided by the hypothesis that an acid/base diet will reduce the degree of acidosis and simultaneously reduce the need for bicarbonate supplements.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

March 27, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

March 13, 2023

Last Update Submit

March 27, 2023

Conditions

Kidney DiseasesMetabolic AcidosisRenal InsufficiencyCKDPre-dialysis

Keywords

Potential renal acid loadPRALStudy designDietHumansElderlyBicarbonate/bloodMuscle strengthHand strengthChair stand testCalorimetry, indirectBone mineralizationCarbon dioxide/bloodPhosphor/urinePotassium/urineUrea/bloodUrea/urine

Outcome Measures

Primary Outcomes (1)

  • Plasma-total carbon dioxide (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

  • +14 more secondary outcomes

Other Outcomes (4)

  • Plasma-Potassium

    6 weeks

  • Plasma-calcium

    6 weeks

  • Plasma-magnesium

    6 weeks

  • +1 more other outcomes

Study Arms (1)

Low PRAL diet

EXPERIMENTAL

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

Other: Low PRAL

Interventions

Low PRALOTHER

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

Low PRAL diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic acidosis (plasma-bicarbonate 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, bricker bladder, pancreatitis or any other known malabsorption problem
  • Potassium above 5 mmol/l
  • Ongoing infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nordshjaellands Hospital

Hillerød, 3400, Denmark

RECRUITING

MeSH Terms

Conditions

Kidney DiseasesAcidosisRenal Insufficiency

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Lisbet Brandi, Doctor Med

    Nordsjaellands Hospital

    PRINCIPAL INVESTIGATOR

  • Jens R Andersen, As. prof.

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise H Salomo, Doctor Med

CONTACT

48293392louise.havkrog.salomo@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2023

First Posted

March 24, 2023

Study Start

March 27, 2023

Primary Completion

June 20, 2023

Study Completion

November 20, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

sharing is not currently possible recording to legislation and consent form.

Locations

DK(1)