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

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:

MedlinePlus related topics: Mercury

U.S. FDA Resources

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.

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.

Show Detailed Description

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

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

Publications:

Aposhian HV. DMSA and DMPS--water soluble antidotes for heavy metal poisoning. Annu Rev Pharmacol Toxicol. 1983;23:193-215. Review. No abstract available.

Clarkson TW, Magos L, Cox C, Greenwood MR, Amin-Zaki L, Majeed MA, Al-Damluji SF. Tests of efficacy of antidotes for removal of methylmercury in human poisoning during the Iraq outbreak. J Pharmacol Exp Ther. 1981 Jul;218(1):74-83.

Chisolm JJ Jr, Thomas DJ. Use of 2,3-dimercaptopropane-1-sulfonate in treatment of lead poisoning in children. J Pharmacol Exp Ther. 1985 Dec;235(3):665-9.

Aposhian HV. Mobilization of mercury and arsenic in humans by sodium 2,3-dimercapto-1-propane sulfonate (DMPS). Environ Health Perspect. 1998 Aug;106 Suppl 4:1017-25.

Gross L. A broken trust: lessons from the vaccine--autism wars. PLoS Biol. 2009 May 26;7(5):e1000114. Epub 2009 May 26. No abstract available.

Torres-Alanís O, Garza-Ocañas L, Bernal MA, Piñeyro-López A. Urinary excretion of trace elements in humans after sodium 2,3-dimercaptopropane-1-sulfonate challenge test. J Toxicol Clin Toxicol. 2000;38(7):697-700.

Responsible Party:	Anne-Michelle Ruha, M.D., Banner Health
ClinicalTrials.gov Identifier:	NCT01059474 History of Changes
Other Study ID Numbers:	DMPS 09-125
Study First Received:	January 19, 2010
Last Updated:	June 21, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Banner Health:

DMPS
mercury

Additional relevant MeSH terms:

Unithiol
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Antidotes
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013