Feasibility Test of Folic Acid on Acute Kidney Injury

Summary

The goal of this clinical trial is to evaluate the feasibility of folic acid supplementation as a treatment for adult patients with acute kidney injury (AKI) receiving hospital care. The main question it aims to answer is: Is it feasible to conduct a fully-powered randomized controlled trial (RCT) to assess the efficacy and safety of folic acid supplementation in AKI management? Researchers will compare two groups (usual care vs. usual care + 5 mg folic acid) to determine the feasibility of folic acid supplementation and estimate the sample size required for a fully powered RCT. Participants will: 1. Receive either usual care, or usual care combined with oral folic acid (5 mg daily) until AKI resolution (up to 30 days); 2. Undergo regular monitoring during hospitalization and follow-ups at 3 months and one year post-discharge.

Timeline

Start

2025-10-01

Primary completion

2027-03-31

Completion

2027-09-30

Publications

• Background Shelton LM, Park BK, Copple IM. Role of Nrf2 in protection against acute kidney injury. Kidney Int. 2013 Dec;84(6):1090-5. doi: 10.1038/ki.2013.248. Epub 2013 Jun 19.
• Background Pietrzik K, Bailey L, Shane B. Folic acid and L-5-methyltetrahydrofolate: comparison of clinical pharmacokinetics and pharmacodynamics. Clin Pharmacokinet. 2010 Aug;49(8):535-48. doi: 10.2165/11532990-000000000-00000.
• Background Scaglione F, Panzavolta G. Folate, folic acid and 5-methyltetrahydrofolate are not the same thing. Xenobiotica. 2014 May;44(5):480-8. doi: 10.3109/00498254.2013.845705. Epub 2014 Feb 4.
• Background Nikolic T, Petrovic D, Matic S, Turnic TN, Jeremic J, Radonjic K, Srejovic I, Zivkovic V, Bolevich S, Bolevich S, Jakovljevic V. The influence of folic acid-induced acute kidney injury on cardiac function and redox status in rats. Naunyn Schmiedebergs Arch Pharmacol. 2020 Jan;393(1):99-109. doi: 10.1007/s00210-019-01717-z. Epub 2019 Aug 27.
• Background Matsuura R, Doi K, Rabb H. Acute kidney injury and distant organ dysfunction-network system analysis. Kidney Int. 2023 Jun;103(6):1041-1055. doi: 10.1016/j.kint.2023.03.025. Epub 2023 Apr 6.
• Background Thomas ME, Blaine C, Dawnay A, Devonald MA, Ftouh S, Laing C, Latchem S, Lewington A, Milford DV, Ostermann M. The definition of acute kidney injury and its use in practice. Kidney Int. 2015 Jan;87(1):62-73. doi: 10.1038/ki.2014.328. Epub 2014 Oct 15.
• Background Yan LJ. Folic acid-induced animal model of kidney disease. Animal Model Exp Med. 2021 Nov 24;4(4):329-342. doi: 10.1002/ame2.12194. eCollection 2021 Dec.
• Background Sharfuddin AA, Molitoris BA. Pathophysiology of ischemic acute kidney injury. Nat Rev Nephrol. 2011 Apr;7(4):189-200. doi: 10.1038/nrneph.2011.16. Epub 2011 Mar 1.
• Background Rahman M, Shad F, Smith MC. Acute kidney injury: a guide to diagnosis and management. Am Fam Physician. 2012 Oct 1;86(7):631-9.
• Background Szeto CC. Perspectives on acute kidney injury strategy: Hong Kong. Nephrology (Carlton). 2018 Oct;23 Suppl 4:104-106. doi: 10.1111/nep.13450.
• Background Hoste EAJ, Kellum JA, Selby NM, Zarbock A, Palevsky PM, Bagshaw SM, Goldstein SL, Cerda J, Chawla LS. Global epidemiology and outcomes of acute kidney injury. Nat Rev Nephrol. 2018 Oct;14(10):607-625. doi: 10.1038/s41581-018-0052-0.
• Background Dasta JF, Kane-Gill S. Review of the Literature on the Costs Associated With Acute Kidney Injury. J Pharm Pract. 2019 Jun;32(3):292-302. doi: 10.1177/0897190019852556.
• Background Negi S, Koreeda D, Kobayashi S, Yano T, Tatsuta K, Mima T, Shigematsu T, Ohya M. Acute kidney injury: Epidemiology, outcomes, complications, and therapeutic strategies. Semin Dial. 2018 Sep;31(5):519-527. doi: 10.1111/sdi.12705. Epub 2018 May 8.
• Background Lameire NH, Bagga A, Cruz D, De Maeseneer J, Endre Z, Kellum JA, Liu KD, Mehta RL, Pannu N, Van Biesen W, Vanholder R. Acute kidney injury: an increasing global concern. Lancet. 2013 Jul 13;382(9887):170-9. doi: 10.1016/S0140-6736(13)60647-9. Epub 2013 May 31.

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