PLADO for Conservative Management of CKD

Last updated: April 9, 2025
Sponsor: Lebanese American University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arginase Deficiency

Metabolic Disorders

Distal Renal Tubular Acidosis

Treatment

Standard-of-care diet

PLADO

Clinical Study ID

NCT06932042
LAU.SAS.RR4.2/Feb/2024
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical trial is to learn if a plant-dominant low protein diet, referred to as PLADO diet, works to decrease metabolic acidosis, a major risk factor for chronic kidney disease (CKD) progression, in adults with CKD. It will also learn about the safety, viability, and economic attractiveness of this diet.

The main questions it aims to answer are:

  • Is the PLADO diet more effective in managing metabolic acidosis in comparison with the standard-of-care CKD diet in adults with CKD?

  • Is the PLADO diet safe, viable, and economically attractive adults with CKD?

Researchers will compare the PLADO diet to the standard-of-care CKD diet to see if the PLADO diet works better to decrease metabolic acidosis.

Participants will:

  • Receive nutrition education of the PLADO diet or the standard-of-care CKD diet via monthly sessions for 6 months.

  • Visit the clinic monthly for 6 months, then after 3 months for checkups and tests.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged 18 years and above, having controlled glycemic and blood pressureparameters on treatment, with an established diagnosis of stages 3-5 CKD and anestimated GFR ≤59 ml/min/1.73 m2 stable for at least three months, and with a normalnutritional status as defined by the GLIM criteria, attending the CKD outpatientclinics at LAUMC-RH, willing to undergo the baseline screening and attend themonthly face-to-face visits at the outpatient department at LAUMC-RH.

Exclusion

Exclusion Criteria:

  • Patients with overt infection, persistent anorexia, vomiting, or diarrhea within thelast month, presence of wasting diseases such as cancer, tuberculosis, liverfailure, heart failure, and those with serum potassium >5.5 mEq/L during the past 6months.

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Standard-of-care diet
Phase:
Study Start date:
May 28, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Lebanese American University Medical Center- Rizk Hospital

    Beirut,
    Lebanon

    Active - Recruiting

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