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Evaluation of Intravenous Ascorbic Acid

Information source: University of Kansas
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Safety and Pharmacokinetics of Intravenous Ascorbate

Intervention: IV Vitamin C (Drug); IV Vitamin C (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: University of Kansas

Official(s) and/or principal investigator(s):
Jeanne Drisko, MD, Principal Investigator, Affiliation: University of Kansas

Overall contact:
Jean Sunega, Phone: 913-588-6104, Email: jsunega@kumc.edu

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.

Clinical Details

Official title: Pharmacokinetic Evaluation of Intravenous Ascorbic Acid

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: identify the maximum tolerated dose (MTD)

Secondary outcome:

measure how the body absorbs, distributes and excretes intravenous ascorbic acid

measure the biochemical and physiological effects of intravenous ascorbic

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.

Eligibility

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

PART 1 ELIGIBILITY CRITERIA Inclusion:

- 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,

- 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. Exclusion:

- 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.

- 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 Inclusion:

- 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. Exclusion:

- 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.

Locations and Contacts

Jean Sunega, Phone: 913-588-6104, Email: jsunega@kumc.edu

University of Kansas Medical Center, Kansas City, Kansas 66160, United States; Recruiting
Jean Sunega, Phone: 913-588-6104, Email: jsunega@kumc.edu
Jeanne Drisko, MD, Principal Investigator
Additional Information

Starting date: May 2011
Last updated: June 12, 2015

Page last updated: August 20, 2015

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