ClinicalTrials.gg
Not yet recruitingNCT07197749Updated Oct 13, 2026

Vitamin C With Steroids for Gastrointestinal GVHD

An Early Phase 1 interventional study of Vitamin C (Ascorbic Acid) in Graft-versus-host-disease (GVHD) and Gastrointestinal, sponsored by Baylor College of Medicine. Not yet recruiting. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Baylor College of Medicine · Early Phase 1, Interventional, and Treatment

Updated Oct 13, 2026Study contact changedGo to Updates ↓
Phase
Early Phase 1
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
5 Years and older
Sex
All
01

Study summary

After a transplant from another donor, one risk is graft versus host disease (GVHD) that happens because of differences between the donated cells (graft) and the patient's body cells (host). The new cells from the donor might see the body's cells as different and attack them. GVHD can be very serious and cause death. The standard first treatment for GVHD is corticosteroids but not all patients respond and in cases where they don't, they need to go onto other treatments that may or may not be effective. In addition, when GHVD involves the gut it can damage the cells of the gastrointestinal track causing long term problems such as abdominal pain and bowel disturbance. In laboratory studies giving a vitamin C has been able to protect the gastrointestinal cells and help them recover. In this trial the investigators would like to see if vitamin C can do the same thing when given with steroids in patients with GVHD.

The standard first treatment for acute GVHD is corticosteroids but not all patients respond and in cases where they don't, they need to go onto other treatments that may or may not be effective. In addition, when GHVD involves the gut it can damage the cells of the gastrointestinal track causing long term problems such as abdominal pain and bowel disturbance. In the laboratory vitamin C has been able to protect gut stem cells and help them recover and the investigators would like to learn if this happens in people too.

Vitamin C is a readily available supplement. Vitamin C has NOT been approved by the FDA for the treatment of acute GVHD.

Read the detailed description

Patients enrolled on this trial will receive vitamin C through the vein or by mouth daily for 56 days. This will start at the same time or within 3 days of starting standard treatment for gut GVHD with steroids.

Medical tests before treatment--

Before being treated, patients will receive a series of standard medical tests:

  • History and Physical exam
  • Blood tests to measure blood cells, kidney and liver function
  • A biopsy of the gut to look for GVHD if possible
  • Serum pregnancy test for female patients who are of childbearing potential
  • An optional stool research sample

Medical tests during and after treatment:

Patients will receive standard medical tests while getting the GVHD treatment and afterwards:

  • History and Physical exams
  • Monitoring for GVHD
  • Blood tests to measure blood cells, kidney and liver function
  • A follow-up biopsy of the gut to look for GVHD if possible

To learn more about the way that vitamin C may work on gut stem cells an extra amount of blood will be obtained on the day vitamin C starts, 2 and 4 weeks after starting the vitamin C. The amount of blood taken will be based on the patients weight with up to a maximum of 60 mL (12 teaspoons) of blood to be obtained at any one time. This volume is considered safe but may be decreased if the patient is anemic (have a low red blood cell count).

If patient has a repeat gut biopsy to check GVHD the investigators will request a sample to be used for research purposes.

Patient will receive supportive care for any acute or chronic toxicities, including blood components or antibiotics, and other intervention as appropriate.

02

Conditions studied

  • Graft-versus-host-disease (GVHD)
  • Gastrointestinal

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Keywords

  • Graft-Versus-Host-Disease
  • GVHD
  • Vitamin C
  • Gastrointestinal
03

In context

Graft vs Host Disease

804 studies on the registry are indexed under Graft vs Host Disease; 149 are open to participants now.

This study's planned enrollment of 35 is close to the median of 35 across 639 interventional studies indexed under Graft vs Host Disease.

Browse Graft vs Host Disease studies →

Lead sponsor

Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.

Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (with or without other organ involvement) or stage 1 LGI + skin aGVHD requiring systemic therapy after transplant for any malignant or non-malignant indication using any graft/donor source or conditioning intensity.
  3. ≥70%
  4. Patients should not have received systemic immune suppressive therapy for treatment of active GVHD except for a maximum of 72 hours of therapy (with or without ruxolitinib) prior to enrollment. Topical skin and GI corticosteroids (such as budesonide and oral beclomethasone diproprionate) are allowed.
  5. explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.

Exclusion criteria

Exclusion Criteria:

  1. , progressing or persistent or evidence of minimal residual disease (MRD) requiring withdrawal of systemic immune suppression.
  2. Patients with acute 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 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 (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.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    Treatment

    Patients will be treated with intravenous (IV) or oral (PO) vitamin C depending on the severity of symptoms, ability to tolerate PO intake, and location of treatment (inpatient versus outpatient setting).

    Drug: Vitamin C (Ascorbic Acid)

Interventions

  • All patients enrolled on this trial will receive steroids at a minimum dose of prednisone 2 mg/kg/day PO (or methylprednisolone 1.6 mg/kg/day IV) divided into 1-2 daily doses as therapy for acute GVHD. For patients that weigh over 100 kg, maximal starting dose of prednisone will be 200 mg (or methylprednisolone-equivalent). Patients will be treated with intravenous (IV) or oral (PO) vitamin C depending on the severity of symptoms, ability to tolerate PO intake, and location of treatment (inpatient versus outpatient setting): IV dosing: 50 mg/kg/day divided TID (max 4 grams total/day) PO dosing: 500 mg BID or 1000 mg daily (depending on the prescribed formulation) Vitamin C will be administered through day 56 from start of vitamin C treatment. Patients initially receiving IV administration may be transitioned to PO formulation once tolerating PO intake; per treating physician discretion.

06

What researchers measure

Primary outcomes

  1. Primary Endpoint

    The primary endpoint is overall (complete or partial) response to combination of vitamin C with steroids at day 28 post-treatment.

    Time frame: 28 days post-treatment

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Oct 2028, 23 months later.

Of 39 non-industry phase 1 interventional studies under Graft vs Host Disease, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 69. This study's planned 23 months is below that.

Counting every sponsor, half of 49 studies reached it within 47 months; a quarter within 24 and three quarters within 65.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2025
First posted
Sep 29, 2025
StartEst.
Nov 2026
Primary completionEst.
Oct 2028
CompletionEst.
Oct 2029
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Contact
Study contact changed: l•••@bcm.edu→l•••@houstonmethodist.org; added b•••@texaschildrens.org · •••4594. See the current contact
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Contact Study contact changed: l•••@bcm.edu→l•••@houstonmethodist.org; added b•••@texaschildrens.org · •••4594. See the current contact
    + 2 other changes: verification date and responsible party

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07197749
Collaborators
The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine
Responsible party
Erin Doherty (Assistant Professor, Baylor College of Medicine) — Principal investigator
First posted
Sep 29, 2025
Start date
Nov 2026 (estimated)
Primary completion
Oct 2028 (estimated)
Completion
Oct 2029 (estimated)
Last update
Oct 13, 2026

Study contacts

LaQuisa Hill, MD
Contact
lchill@houstonmethodist.org
713-441-1450
Brandon Garner
Contact
bjgarner@texaschildrens.org
832-824-4594
LaQuisa Hill, MD
principal investigator · Baylor College of Medicine
Erin Doherty, MD
principal investigator · Baylor College of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ascorbic Acid

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