Pharmacokinetic Evaluation of Intravenous Ascorbic Acid
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- identify the maximum tolerated dose (MTD)
Study Overview
Brief Summary
This Phase I study will be conducted in 2 parts to examine safety and pharmacokinetics of escalating doses of intravenous ascorbic acid (AA) first in healthy volunteers followed by evaluation in oncology subjects. The study will be conducted in the Program in Integrative Medicine Infusion Clinic at the University of Kansas Medical Center in conjunction with the Program in Integrative Medicine, Kansas Cancer Research Institute, Department of Pharmacy, Department of Medical Oncology, the Division of Surgical Oncology,and with consultants from the NIH, and FDA.
Detailed Description
The purpose of this study is to examine what happens when Vitamin C enters into the body, and the speed and ways it travels through the body, and the rate at which it exits the body in the urine. It is also necessary to determine if it is safe to give Intravenous Vitamin C at high doses.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Phase I, IV Vitamin C Healthy Normals
Safety and pharmacokinetics of intravenous ascorbate,IV Vitamin C.
Intervention: IV Vitamin C (Drug)
Phase 1 IV Vitamin C- Cancer Patients
Safety and pharmacokinetics of intravenous ascorbate,IV Vitamin C.
Intervention: IV Vitamin C (Drug)
Outcomes
Primary Outcomes
identify the maximum tolerated dose (MTD)
Time Frame: Change from infusion to 24 hours past infusion
This will be accomplished by obtaining the following evaluations: toxicity graded by the NCI CTC, urinalysis pre- and post-infusion, ECG, basic metabolic panel, bicarbonate (pH surrogate marker), CBC, and osmolality.
Secondary Outcomes
- measure how the body absorbs, distributes and excretes intravenous ascorbic acid(0,.5,1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 24 hours post-dose)
- measure the biochemical and physiological effects of intravenous ascorbic(0,.5,1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 24 hours post-dose)
Investigators
Jeanne Drisko, MD, CNS, FACN
Riordan Endowed Professor of Orthomolecular Medicine
University of Kansas Medical Center