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NCT07612345 · ClinicalTrials.gov registry record · Phase 1
High-Dose Vitamin C in G6PDA and Pyruvate Kinase Deficiency: A Safety Study
A Phase 1 study, sponsored by University of Utah.
- Not yet
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT07612345 is a Phase 1 study that has not yet begun recruiting, run by University of Utah. The registered enrollment target is 3 participants.
The verdict
NCT07612345, a Phase 1 study, has not yet begun recruiting, sponsored by University of Utah.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This study is testing whether high-dose Vitamin C is safe and well-tolerated in patients with two inherited red blood cell disorders - Pyruvate Kinase Deficiency (PKD) and Class A Glucose-6-Phosphate Dehydrogenase Deficiency (G6PDA). Both conditions cause red blood cells to break down too quickly, leading to anemia and related complications. Our earlier research showed that a single oral dose of Vitamin C (250 mg, 500 mg, or 750 mg) reduced red blood cell breakdown by approximately 50% within one hour. This study builds on those findings by testing different doses and frequencies of Vitamin C to find the safest and most effective dosing schedule. Participants will take Vitamin C once, twice, or three times daily over a 3-week period, with careful monitoring of blood counts, red blood cell survival, iron levels, and any side effects. The study will first enroll 3 adult patients with PKD at Huntsman Cancer Institute. If the results are safe and promising, the study will be extended to patients with G6PDA deficiency, and eventually to children ages 4 and older at Primary Children's Hospital in Salt Lake City. The goal is to establish a foundation for Vitamin C as a novel therapy to reduce anemia and red blood cell destruction in these rare inherited disorders.
Interventions
- DRUG Vitamin C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2026-07-15 |
| Est. Completion | 2027-12-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07612345
The ClinicalTrials.gov registry entry for NCT07612345 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vitamin C is the first listed.
NCT07612345 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07612345 about?
NCT07612345 is a clinical study titled "High-Dose Vitamin C in G6PDA and Pyruvate Kinase Deficiency: A Safety Study". This study is testing whether high-dose Vitamin C is safe and well-tolerated in patients with two inherited red blood cell disorders - Pyruvate Kinase Deficiency (PKD) and Class A Glucose-6-Phosphate Dehydrogenase Deficiency (G6PDA). Both conditions cause red blood cells to break down too quickly, l...
What is the current status of trial NCT07612345?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2026-07-15. Estimated completion is 2027-12-15.
What interventions are being tested in trial NCT07612345?
The interventions under investigation include: Vitamin C (DRUG).
Who is sponsoring clinical trial NCT07612345?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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