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Feasibility Test of Folic Acid on Acute Kidney Injury
Sponsor: The University of Hong Kong
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.
Official title: Efficacy and Safety of Folic Acid on Acute Kidney Injury in Adults: A Feasibility Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2025-10-01
Completion Date
2027-09-30
Last Updated
2025-07-15
Healthy Volunteers
No
Conditions
Interventions
Folic Acid 5 MG
In this study, oral folic acid at 5 mg/d (\~83.3 μg/kg) is chosen. In a rat model of AKI with ischaemia-reperfusion, intraperitoneal injection of 5-methyltetrahydrofolate (5-MTHF) at 3 μg/kg body weight twice (30 min before ischaemia and 3 h after reperfusion) improved kidney function and alleviated oxidative stress within 24 hours. The average body weight is around 60 kg for Chinese. Considering the oral route often requires larger doses than injection to produce the same effect, oral folic acid at 5 mg/d (\~83.3 μg/kg) is chosen to test its effect on AKI. Depending on the clinical condition, the therapeutic dose of folic acid varies. For foetal support during pregnancy, daily doses of 1 mg of folic acid are recommended; for lowering homocysteine, up to 5 mg daily are generally used.
Locations (1)
Queen Mary Hospital
Hong Kong, Hong Kong, Hong Kong