Vitamin B9 may boost survival after Infection-Linked kidney damage
NCT ID NCT07377071
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether taking folic acid (vitamin B9) daily for 90 days can lower the risk of death within one year for adults with acute kidney injury caused by infections. About 382 participants will either receive folic acid plus standard care or standard care alone. Researchers will also check if folic acid helps kidneys recover faster and prevents long-term kidney problems.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 382 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients will be eligible for the study if ALL the following are present: 1. Adults ≥18 years of age 2. Presence of an infection (defined by clinical signs/symptoms such as fever, chills, or laboratory evidence; or presumed infection indicated by blood culture obtained and at least 4 Qualifying Antimicrobial Days starting within 2 calendar days before/after blood culture; or physician's judgment) 3. Diagnosed with AKI based on KDIGO criteria: increase in serum creatinine by ≥0.3 mg/dL (26.5 µmol/L) within 48 hours, OR increase to ≥1.5 times baseline, OR urine output \<0.5 mL/kg/h for ≥6 hours (baseline creatinine is the median from 8-365 days prior, or lowest from 0-7 days if unavailable) 4. Ability to provide informed consent or having a legally authorized representative to provide consent Exclusion Criteria: Patients will be excluded from the study if any of the following conditions is present. 1. Patients with AKI due to causes not related to infections or sepsis (e.g., nephrotoxic drugs, obstruction of urinary flow) 2. Known hypersensitivity or contraindication to folate (folic acid) 3. Pregnancy or breastfeeding women 4. Already on folate treatment at the time of screening
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Queen Mary Hospital
Hong Kong, Hong Kong, Hong Kong