Transdermal Absorption of Dimercaptopropane-1-Sulfonate (DMPS) and Effect on Urinary Mercury Excretion
DMPS is a metal chelator which is approved for use in Europe. While not an FDA-approved drug in the US, it is easily obtained and administered by alternative health practitioners to their patients. A formulation called 'TD DMPS' (transdermal DMPS) is in use, despite the fact there is no published literature to support that the agent is absorbed transdermally. The investigators hypothesis is that DMPS is not absorbed through the skin. The investigators plan to apply TD DMPS to healthy volunteers and then test serum for presence of DMPS. In addition the investigators will measure urinary mercury concentrations pre and post DMPS application.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Transdermal Absorption of DMPS and Its Effect on Urinary Mercury Excretion|
- serum DMPS level [ Time Frame: within 6 hours of application ] [ Designated as safety issue: No ]
- change in urinary mercury excretion [ Time Frame: 12 hours preceeding and following DMPS ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
We will recruit 10 healthy adult volunteers, over 18 years of age, who eat at least three servings of fish per week (since this diet is associated with detectable levels of mercury in the urine which may rise following chelation). Patients with known allergies to DMPS or sulfa drugs or history of neurologic or renal disease will be excluded. We will also control for number of mercury containing dental amalgams. History will be obtained regarding any potential mercury exposures or recent vaccinations.
Drug: transdermal DMPS
12 hr urine mercury and creatinine levels will be measured on all volunteers prior to any treatment. The urine will be collected in acid-washed or heavy-metal-free specialty containers. Each volunteer will then receive 120 mg of transdermal DMPS, applied to the bicep area of one arm. The area of application will not exceed 2% body surface area. After dosing, urine will be collected for the next 12 hours (using the same protocol and send-out procedure) and assayed for mercury and creatinine levels.
Additionally, after dosing, an intravenous catheter will be placed in the arm of each subject for blood draws. Blood samples will be obtained at 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours and 6 hours after application of the DMPS.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059474
|United States, Arizona|
|Department of Medical Toxicology|
|Phoenix, Arizona, United States, 85006|
|Principal Investigator:||Anne-Michelle Ruha, M.D.||Banner Health|