NCT01833351

Evaluation of Intravenous Ascorbic Acid

Pharmacokinetic Evaluation of Intravenous Ascorbic Acid

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Conditions

• Safety and Pharmacokinetics of Intravenous Ascorbate

Interventions

Type	Name	Description
DRUG	IV Vitamin C	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.
DRUG	IV Vitamin C	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.

Timeline

• Start date: 2011-05-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2013-04-16
• Last updated: 2015-11-06

Locations

1 site across 1 country: United States