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d-Alanine Supplementation for Chronic Kidney Disease: A Study Protocol for a Pilot Randomized Controlled Trial
Megumi Oshima1, Tadashi Toyama1,2, Yusuke Nakade3
1Department of Nephrology and Rheumatology, Kanazawa University, Kanazawa, Japan.
This pilot study explored d-alanine for chronic kidney disease (CKD) patients. Results will guide larger trials on d-alanine
Area of Science:
- Nephrology
- Nutritional Science
- Clinical Trials
Background:
- Chronic kidney disease (CKD) patients face high risks of kidney failure and cardiovascular events.
- Previous research indicated d-alanine may prevent kidney damage in acute kidney injury models.
- Novel nutritional interventions are needed for CKD management.
Purpose of the Study:
- To assess the efficacy and safety of d-alanine supplementation in patients with CKD.
- To gather data for designing a larger, definitive clinical trial.
- To explore d-alanine's potential as a nutritional therapy for kidney health.
Main Methods:
- Pilot, open-label, randomized controlled trial.
- 24 patients with sustained albuminuria or proteinuria enrolled.
- Intervention: 3g daily d-alanine for 12 weeks versus standard care.
- Primary endpoint: Change in albuminuria; Secondary endpoints: eGFR and clinical parameters.
Main Results:
- This section is to be filled after the trial concludes.
- Data on changes in albuminuria, eGFR, and safety profiles will be reported.
- Pilot data will inform sample size and design for future studies.
Conclusions:
- Findings are expected to guide the design of a larger clinical trial.
- This study will support the potential development of d-alanine for nutritional management of CKD.
- Further research is warranted to establish d-alanine's role in CKD treatment.
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