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OpenTrials
Completed

NCT Number: NCT05970094

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nordshjaellands Hospital

Hillerød, 3400, Denmark

About this study

Observational studies indicate that diets with a low "potential renal acid load (PRAL)" is associated with a lower serum-bicarbonate value. The aim is to investigate this association with an interventional studydesign.

Participants will be asked to follow a restricted diet with a low "PRAL" during a 6 week trial divided in three periodes: two week free living control, two week intervention and a two week free living follow-up.

The PRAL calculation tool will be used to create a diet low in acid, based on this the patients will receive individual diet plans. The diet will comply with national treshold guidelines for potassium and protein, this is due to the high risk of hyperkalemia in patients with chronic kidney disease. The patients will be asked to document their food and drink intake by taking pictures of their plates and cups before and after a meal, over a 24 hour period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Low PRAL

Other

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

Primary outcomes

  1. Plasma-total CO2

    Time frame: 6 weeks

    mmol/l

Secondary outcomes

  1. Plasma-alkaline phosphatase

    Time frame: 6 weeks

    U/l

  2. Plasma-sodium ion

    Time frame: 6 weeks

    mmol/l

  3. Plasma-creatinine

    Time frame: 6 weeks

    umol/l

  4. Plasma-parathyroid hormone

    Time frame: 6 weeks

    pmol/l

  5. Plasma-carbamide

    Time frame: 6 weeks

    mmol/l

  6. Plasma-albumin

    Time frame: 6 weeks

    g/l

  7. Urine-phosphorous

    Time frame: 6 weeks

    mmol/d

  8. Urine-sodium

    Time frame: 6 weeks

    mmol/d

  9. Urine-potassium

    Time frame: 6 weeks

    mmol/d

  10. Urine-carbamide

    Time frame: 6 weeks

    mmol/d

  11. Urine-albumin

    Time frame: 6 weeks

    mg/d

  12. Urine-magnesium

    Time frame: 6 weeks

    mmol/d

  13. Urine-creatinine

    Time frame: 6 weeks

    mmol/d

  14. Uirne-calcium

    Time frame: 6 weeks

    mmol/d

  15. Total acid excretion in urine

    Time frame: 6 weeks

    meqv/day

  16. Urine-pH

    Time frame: 6 weeks

    Units

  17. Urine NH4+ excretion

    Time frame: 6 weeks

    mmol/day

  18. Urine net acid excretion

    Time frame: 6 weeks

    meqv/day

  19. Urine bicarbonate

    Time frame: 6 weeks

    mmol/l

Other outcomes

  1. Plasma-Potassium

    Time frame: 6 weeks

    mmol/l

  2. Plasma-calcium

    Time frame: 6 weeks

    mmol/l

  3. Plasma-magnesium

    Time frame: 6 weeks

    mmol/l

  4. Plasma-inorganic phosphorous

    Time frame: 6 weeks

    mmol/l

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Nordsjaellands Hospital

Registry information

Acronym: REMA-CKD

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2023
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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