Transdermal Absorption of Dimercaptopropane-1-Sulfonate (DMPS) and Effect on Urinary Mercury Excretion

This study has been completed.
Sponsor:
Collaborator:
Phoenix Children's Hospital
Information provided by:
Banner Health
ClinicalTrials.gov Identifier:
NCT01059474
First received: January 19, 2010
Last updated: June 21, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Toxicity
Drug: transdermal DMPS
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Banner Health:

Primary Outcome Measures:
  • serum DMPS level [ Time Frame: within 6 hours of application ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in urinary mercury excretion [ Time Frame: 12 hours preceeding and following DMPS ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: April 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DMPS
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.


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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult

Exclusion Criteria:

  • Under 18 years of age
  • Allergy to sulfa
  • Eat less than three fish servings per week
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01059474

Locations
United States, Arizona
Department of Medical Toxicology
Phoenix, Arizona, United States, 85006
Sponsors and Collaborators
Banner Health
Phoenix Children's Hospital
Investigators
Principal Investigator: Anne-Michelle Ruha, M.D. Banner Health
  More Information