Safety and Pharmacokinetics of Intravenous AscorbatePhase 1NCT01833351
Evaluation of Intravenous Ascorbic Acid
A Phase 1 study testing IV Vitamin C in people with Safety and Pharmacokinetics of Intravenous Ascorbate, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Safety and Pharmacokinetics of Intravenous Ascorbate
- What is being tested?
- IV Vitamin C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Oct 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults age 21 or older
- Laboratory: ANC ≥1,500/mm3,
- Hemoglobin > 8g/dL,
- platelet ≥ 100,000/mm3,
- total bilirubin ≤ 1.5 mg/dL,
- creatinine ≤2.0 mg/dL,
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- transaminase (AST/ALT) ≤2.5X upper limit,
- urine uric acid < 1,000mg/d,
- urine pH <6,
- urine oxalate <60 mg/d.
- Participants who have no language barrier, are cooperative, and can give informed consent before entering the study after being informed of the medications and procedures to be used in this study may participate.
- Oncology participants must have histologically or cytologically diagnosed malignancy.
- The oncology participants must be age 21 or older and screened for eligibility and have study approved by treating oncologist.
- Oncology participants must be unwilling or ineligible for further radiation or chemotherapy at the time of enrollment into study.
- Participants must be without evidence of active spinal cord compression and have predicted lifespan of 6-months or more.
- ECOG Performance Status 0-2
- Eastern Cooperative Oncology Group Performance Status
- Grade 0 = Fully active, able to carry on all pre-disease activities without restriction
- Grade 1= Restricted in physical strenuous activity but ambulatory and able to carry out work of a light or sedentary nature e.g. light housework, office work
- Grade 2 = Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours.
- Laboratory:
- ANC ≥1,500/mm3,
- Hemoglobin > 8g/dL,
- platelet ≥ 100,000/mm3,
- total bilirubin ≤ 1.5 mg/dL,
- creatinine ≤2.0 mg/dL,
- transaminase (AST/ALT) ≤2.5X upper limit,
- urine uric acid < 1,000mg/d, urine pH <6,
- urine oxalate <60 mg/d.
- Participants who have no language barrier, are cooperative, and can give informed consent before entering the study after being informed of the medications and procedures to be used in this study may participate.
Who cannot join
- Glucose-6-phosphate-dehydrogenase (G6PD) deficiency
- History of bleeding disorder
- History of oxalate renal calculi; urine oxalate level > 60 mg/d at baseline
- History of iron overload or hemochromatosis
- Participants with evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study will not be allowed to participate.
- Co-morbid condition that would affect survival: end stage congestive heart failure, unstable angina, myocardial infarction within 6 weeks of study, uncontrolled blood sugars ≥ 300 mg/dL, participants with known chronic active hepatitis or cirrhosis.
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- Participants who consume an excess of alcohol or abuse drugs (an excess of alcohol is defined as more than four of any one of the following per day: 30mL distilled spirits, 340mL beer, or 120mL wine) will not be allowed.
- Participants who smoke tobacco products will not be allowed to participate.
- PART 2 ELIGIBILITY CRITERIA
- Glucose-6-phosphate-dehydrogenase (G6PD) deficiency
- Currently receiving chemotherapy or radiation therapy
- History of bleeding disorder
- History of oxalate renal calculi; urine oxalate level > 60 mg/d at baseline
- History of iron overload or hemochromatosis
- Participants with evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study will not be allowed to participate.
- ECOG Performance Status of 3-4
- Grade 3 = Capable of only limited self care, confined to bed or chair more than 50% of waking hours.
- Grade 4 = Completely disabled. Cannot carry on any self care. Totally confined to bed or chair) and in terminal stages of disease.
- Co-morbid condition that would affect survival: end stage congestive heart failure, unstable angina, myocardial infarction within 6 weeks of study, uncontrolled blood sugars ≥ 300 mg/dL, participants with known chronic active hepatitis or cirrhosis.
- Those who consume an excess of alcohol or abuse drugs (an excess of alcohol is defined as more than four of any one of the following per day: 30mL distilled spirits, 340mL beer, or 120mL wine) will not be allowed.
- Those who smoke tobacco products will not be allowed to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Pharmacokinetic Evaluation of Intravenous Ascorbic Acid
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.
Read the 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.
- Being tested
- IV Vitamin C
- Keywords
- Phase I, safety and pharmacokinetics,, intravenous ascorbate,, IV Vitamin C,, Oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Vitamin CDrug
Also called IV Ascorbate
We will begin by enrolling 3 people at each dose level and if there are any problems seen, we will enroll 3 more people to that dose to see if that problem happens again and this may total a maximum of 6 people. Therefore a maximum of 6 people may be enrolled at each of these Vitamin C dose levels, 1 gram, 5 grams, 10 grams, 25 grams, 50 grams, 75 grams, and 100 grams.
If you are eligible for the study and decide to participate, the total time involved could be approximately 4 weeks.
IV Vitamin CDrug
Also called IV Ascorbate
There will be 4 dose levels of intravenous vitamin C selected for this part of the study. The first dose level will be 25% of the top dose level found to be safe in Part 1, followed by 50% of the top dose level, followed by 75% of the top dose level, and finally 100% of the top dose. For example, if 100 grams of vitamin C given by vein is found to be safe in Part 1, then the first dose level we will choose will be 25 grams, followed by 50 grams, then 75 grams, and finally 100 grams.
Three to 6 people will be invited to participate in each of the dose levels and you will be asked to get a total of 4 doses at that level spread out over 4 weeks. In addition, you will have an initial visit and a follow-up visit both lasting 30 minutes. This will total 6 visits.
| Study group | Role | What they receive |
|---|---|---|
| Phase I, IV Vitamin C Healthy Normals | Experimental | Safety and pharmacokinetics of intravenous ascorbate,IV Vitamin C. Receives: Drug: IV Vitamin C |
| Phase 1 IV Vitamin C- Cancer Patients | Experimental | Safety and pharmacokinetics of intravenous ascorbate,IV Vitamin C. Receives: Drug: IV Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
identify the maximum tolerated dose (MTD)
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.
Measured: Change from infusion to 24 hours past infusion
Secondary outcomes (2)
measure how the body absorbs, distributes and excretes intravenous ascorbic acid
The pro-drug ascorbic acid will be administered intravenously in escalating doses of 1, 5, 10, 25, 50, 75, and 100 grams and infused over 120 minutes with sampling pre, during, and post infusion up to 24 hours in 21 healthy adults and 12 oncology participants who unable or unwilling to receive further cytoreductive therapy.
Measured: 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
The pro-drug ascorbic acid will be administered intravenously in escalating doses of 1, 5, 10, 25, 50, 75, and 100 grams and infused over 120 minutes with sampling pre, during, and post infusion up to 24 hours in 21 healthy adults and 12 oncology participants who unable or unwilling to receive further cytoreductive therapy.
Measured: 0,.5,1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startMay 2011
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Safety and Pharmacokinetics of Intravenous AscorbateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas Jefferson University
- Responsible party
- Principal investigator, Jeanne Drisko, MD, CNS, FACN, University of Kansas Medical Center
- Investigators
- Jeanne Drisko, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833351
- Sponsor's protocol ID
- 12680
- Status last verified
- Nov 2015
- First submitted
- 30 May 2012
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen P, Reed G, Jiang J, Wang Y, Sunega J, Dong R, Ma Y, Esparham A, Ferrell R, Levine M, Drisko J, Chen Q. Pharmacokinetic Evaluation of Intravenous Vitamin C: A Classic Pharmacokinetic Study. Clin Pharmacokinet. 2022 Sep;61(9):1237-1249. doi: 10.1007/s40262-022-01142-1. Epub 2022 Jun 25.
PubMed 35750958
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Evaluation of Intravenous Ascorbic Acid
- ClinicalTrials.gov ID
- NCT01833351
- Acronym / sponsor ID
- 12680
- Keywords
- Phase I, safety and pharmacokinetics,, intravenous ascorbate,, IV Vitamin C,, Oncology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Thomas Jefferson University
- Study start
- May 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I, IV Vitamin C Healthy Normals | Experimental | Drug: IV Vitamin CSafety and pharmacokinetics of intravenous ascorbate,IV Vitamin C. |
| Phase 1 IV Vitamin C- Cancer Patients | Experimental | Drug: IV Vitamin CSafety and pharmacokinetics of intravenous ascorbate,IV Vitamin C. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Healthy adults age 21 or older
- Laboratory: ANC ≥1,500/mm3,
- Participants who have no language barrier, are cooperative, and can give informed consent before entering the study after being informed of the medications and procedures to be used in this study may participate.
- Oncology participants must have histologically or cytologically diagnosed malignancy.
- The oncology participants must be age 21 or older and screened for eligibility and have study approved by treating oncologist.
Key exclusion criteria (21 listed)
- Glucose-6-phosphate-dehydrogenase (G6PD) deficiency
- History of bleeding disorder
- History of oxalate renal calculi; urine oxalate level > 60 mg/d at baseline
- History of iron overload or hemochromatosis
- Participants with evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study will not be allowed to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV Vitamin CAlso: IV AscorbateWe will begin by enrolling 3 people at each dose level and if there are any problems seen, we will enroll 3 more people to that dose to see if that problem happens again and this may total a maximum of 6 people. Therefore a maximum of 6 people may be enrolled at each of these Vitamin C dose levels, 1 gram, 5 grams, 10 grams, 25 grams, 50 grams, 75 grams, and 100 grams. If you are eligible for the study and decide to participate, the total time involved could be approximately 4 weeks. | Drug | Phase 1 IV Vitamin C- Cancer Patients, Phase I, IV Vitamin C Healthy Normals |
| IV Vitamin CAlso: IV AscorbateThere will be 4 dose levels of intravenous vitamin C selected for this part of the study. The first dose level will be 25% of the top dose level found to be safe in Part 1, followed by 50% of the top dose level, followed by 75% of the top dose level, and finally 100% of the top dose. For example, if 100 grams of vitamin C given by vein is found to be safe in Part 1, then the first dose level we will choose will be 25 grams, followed by 50 grams, then 75 grams, and finally 100 grams. Three to 6 people will be invited to participate in each of the dose levels and you will be asked to get a total of 4 doses at that level spread out over 4 weeks. In addition, you will have an initial visit and a follow-up visit both lasting 30 minutes. This will total 6 visits. | Drug | Phase 1 IV Vitamin C- Cancer Patients, Phase I, IV Vitamin C Healthy Normals |
Primary outcome
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.
2 secondary outcomes
measure how the body absorbs, distributes and excretes intravenous ascorbic acid
Time frame: 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
Time frame: 0,.5,1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 24 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
- Derived from this study: PubMed 35750958Chen P, Reed G, Jiang J, Wang Y, Sunega J, Dong R, Ma Y, Esparham A, Ferrell R, Levine M, Drisko J, Chen Q. Pharmacokinetic Evaluation of Intravenous Vitamin C: A Classic Pharmacokinetic Study. Clin Pharmacokinet. 2022 Sep;61(9):1237-1249. doi: 10.1007/s40262-022-01142-1. Epub 2022 Jun 25.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanne Drisko, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IV Vitamin C in people with Safety and Pharmacokinetics of Intravenous Ascorbate, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
identify the maximum tolerated dose (MTD) (time frame: Change from infusion to 24 hours past infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01833351, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2015.