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Folate Treatment to Reduce Death Risk in the Year After Infection-Related Acute Kidney Injury
Sponsor: The University of Hong Kong
Summary
The goal of this clinical trial is to evaluate if taking folic acid (a form of vitamin B9) can help reduce the risk of death and improve kidney recovery in adults with acute kidney injury (AKI) caused by infections or sepsis. The main question it aims to answer is: Does taking folic acid lower the chance of dying within one year for these patients? This study will also look at other important questions, such as whether folic acid helps kidneys recover faster (within 7 days), prevents long-term kidney problems (progression to chronic kidney disease at 3 months), reduces heart-related events, and is safe. Researchers will compare the group receiving folic acid (5 mg taken by mouth once daily for 90 days, plus usual care) to the group receiving only usual care (standard treatments like fluids, blood pressure control, antibiotics, and stopping harmful medicines) to see if folic acid provides extra benefits. Participants will: 1. Be randomly assigned to one of the two groups 2. Receive usual hospital care for their infection and AKI 3. Take the folic acid (or not, depending on their group) every day for 3 months 4. Have blood tests at the start and at 3 months (including to check serum folate levels) 5. Be followed up for 1 year through clinic visits, phone calls, or medical records to track health outcomes like survival, kidney function, and any side effects This open-label study (both patients and doctors know which treatment is given) will include about 382 adults at Queen Mary Hospital in Hong Kong. It builds on earlier retrospective study data suggesting folic acid might improve survival in similar patients.
Official title: Impact of Folate Administration on One-Year Mortality in Patients With Infection-Associated Acute Kidney Injury: An Open-Label Randomised Controlled Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
382
Start Date
2026-04-01
Completion Date
2029-03-31
Last Updated
2026-01-29
Healthy Volunteers
No
Conditions
Interventions
Folic Acid 5 MG
Oral folic acid 5 mg once daily for 90 days, administered as standard tablets (or via nasogastric tube if oral intake is not possible). Treatment is initiated immediately after randomization and diagnosis of infection-associated acute kidney injury (AKI per KDIGO criteria) and is given in addition to standard supportive AKI care. This low-dose regimen is selected based on preclinical evidence of oxidative stress reduction and Nrf2 activation in rat ischemia-reperfusion AKI models at low doses, and retrospective human data showing potential mortality benefit in infection-related AKI at similar oral doses (typically 5 mg daily). Duration of 90 days targets both acute recovery and early prevention of progression to chronic kidney disease (CKD). This differs from high-dose folic acid models (e.g., 250 mg/kg) used experimentally to induce AKI via crystal nephropathy, and from folate interventions in CKD or other populations.
Locations (1)
Queen Mary Hospital
Hong Kong, Hong Kong, Hong Kong