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Feasibility Test of Folic Acid on Acute Kidney Injury

NCT07013136 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-07-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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.

Sponsors & Collaborators

  • Queen Mary Hospital, Hong Kong

    collaborator OTHER

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Timothy H Rainer, MBBCh · Department of Emergency Medicine, The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2027-03-31
Completion
2027-09-30

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07013136 on ClinicalTrials.gov