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Effects of Keto/amino Acids Supplementation on Quality of Life in Palliative Care of End Stage Kidney Disease Patient, A Randomized Controlled Trial

Effects of Keto/amino Acids Supplementation on Quality of Life in Palliative Care of End Stage Kidney Disease Patient, A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20221111001
Enrollment
106
Registered
2022-11-11
Start date
2022-01-07
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Palliative care of non-diabetic chronic kidney disease stage 5 who denied long-term renal replacement therapy Palliative care, end-stage kidney disease, denied renal replacement therapy

Interventions

Oral Keto amino acid tablet dose 600 mg/ 5 Kg of ideal body weight/day with a very low protein diet (VLPD) providing 0.3 g dietary protein/Kg ideal body weight/day with energy intake of 30 -35 kcal/kg
Experimental Drug,No Intervention No treatment
Keto amino acid and very low protein diet,Low protein diet

Sponsors

Clinical Research Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: 1. estimated GFR (CKD-EPI) < 6 mL/min/1.73 m2 without uremic symptoms 2. estimated GFR (CKD-EPI) over 6 - < 15 mL/min/1.73 m2 with uremic symptoms 3. denied receiving long-term renal replacement therapy by their wills

Exclusion criteria

Exclusion criteria: 1. acute life-threatening disease 2. urine protein excretion greater than 3 g/d, liver failure 3. human immunodeficiency virus infection 4. previous episodes of cardiac failure, 5. diabetes mellitus 6. active malignancies other than basal cell carcinoma 7. chronic obstructive pulmonary diseases requiring supplementary oxygen 8. a significant disorder of amino acid metabolism, e.g. hereditary diseases. 9. Participation in an interventional clinical trial during the last 2 months before individual enrolment of the patient 10. known allergic reactions to the active ingredients or constituents of the pharmaceutical preparation 11. pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Quality of life, effect of kidney disease every 2 months for 6 months sub score of KDQOL

Secondary

MeasureTime frame
Metabolic profile and blood chemistries every 2 months for 6 months Electrolyte, CBC, Ca, Phosphate level, Lipid profile,Inflammatory markers every 2 months for 6 months interleukin-6, CRP,Nutritional assessment every 2 months for 6 months SGA score, albumin, prealbumin,Renal function every 2 months for 6 months eGFR,total score of KDQOL every 2 months for 6 months KDQOL score,Mortality rate every 2 months for 6 months time to event of dead with renal failure ,Rate and time to initial dialysis every 2 months for 6 months time to event

Countries

Thailand

Contacts

Public ContactParamat Thimachai

Phramongkutklao hospital

pthimachai@pcm.ac.th0894189669

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026