Could vitamin c help protect the gut in transplant patients?
NCT ID NCT07197749
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times
Summary
This early-phase trial tests whether adding vitamin C to standard steroid treatment helps people with gastrointestinal graft-versus-host disease (GVHD), a serious complication after a donor stem cell transplant. About 35 participants aged 5 and older will receive vitamin C plus steroids to see if it improves response at day 28. Lab studies suggest vitamin C may protect and repair gut cells damaged by GVHD.
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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 35 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 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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5 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients 5 years of age or older at time of enrollment. 2. Patients experiencing their initial presentation of stage 2 or greater acute LGI GVHD (with or without other organ involvement) or stage 1 LGI + skin aGVHD requiring systemic therapy after allogeneic transplant for any malignant or non-malignant indication using any graft/donor source or conditioning intensity. 3. KPS ≥70% 4. Patients should not have received systemic immune suppressive therapy for treatment of active GVHD except for a maximum of 72 hours of steroid therapy (with or without ruxolitinib) prior to enrollment. Topical skin and GI corticosteroids (such as budesonide and oral beclomethasone diproprionate) are allowed. 5. Informed Consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. Exclusion Criteria: 1. Relapsed, progressing or persistent malignancy or evidence of minimal residual disease (MRD) requiring withdrawal of systemic immune suppression. 2. Patients with acute GVHD developing after administration of a donor lymphocyte infusion (DLI) for relapse/progression of disease. 3. Patients with uncontrolled infections will be excluded. Infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms 4. Known or suspected hypersensitivity to vitamin C. 5. De novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment. 6. Patients receiving other drugs for the treatment of GVHD except as noted above. GVHD prophylaxis agents (e.g., calcineurin inhibitors) may be continued at local Investigator's discretion. 7. Patients on renal replacement therapy. 8. Patients requiring continuous supplemental oxygen \> 2L/min to maintain peripheral O2 saturation \[SpO2\] \> 90%. 9. Patients with active hepatic sinusoidal obstructive syndrome (SOS) and/or clinical evidence of impaired hepatic function (ascites or encephalopathy related to liver disease. 10. Patients receiving systemic corticosteroids (CS) for any indication within 7 days before enrollment, except the following: 1. Corticosteroids administered as premedication for supportive care (such as before transfusion of blood products or before intravenous medications to prevent infusion reactions, fever, etc.). 2. If steroid therapy has been administered for treatment of a non-GVHD related condition and tapered to \< 0.6 mg/kg/day prednisone (0.5 mg/kg/day methylprednisolone) for 7 or more days prior to enrollment. 11. History of G6PD deficiency, sickle cell disease or hemochromatosis. 12. History of oxalate kidney stones. 13. Patients unlikely to be adherent to study specific assessments at the transplant center.
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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 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.
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Other studies related to the condition(s) this trial covers.
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