NCT01059474

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 1, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 22, 2011

Status Verified

May 1, 2011

Enrollment Period

8 months

First QC Date

January 19, 2010

Last Update Submit

June 21, 2011

Conditions

Toxicity

Keywords

DMPSmercury

Outcome Measures

Primary Outcomes (1)

  • serum DMPS level

    within 6 hours of application

Secondary Outcomes (1)

  • change in urinary mercury excretion

    12 hours preceeding and following DMPS

Study Arms (1)

DMPS

EXPERIMENTAL

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

Interventions

transdermal DMPSDRUG

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.

DMPS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult

You may not qualify if:

  • Under 18 years of age
  • Allergy to sulfa
  • Eat less than three fish servings per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Toxicology

Phoenix, Arizona, 85006, United States

Location

Related Publications (6)

  • Aposhian HV. DMSA and DMPS--water soluble antidotes for heavy metal poisoning. Annu Rev Pharmacol Toxicol. 1983;23:193-215. doi: 10.1146/annurev.pa.23.040183.001205. No abstract available.

    PMID: 6307120BACKGROUND

  • 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.

    PMID: 7241391BACKGROUND

  • 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.

    PMID: 4078728BACKGROUND

  • 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(Suppl 4):1017-25. doi: 10.1289/ehp.98106s41017.

    PMID: 9703487BACKGROUND

  • Gross L. A broken trust: lessons from the vaccine--autism wars. PLoS Biol. 2009 May 26;7(5):e1000114. doi: 10.1371/journal.pbio.1000114. Epub 2009 May 26.

    PMID: 19478850BACKGROUND

  • Torres-Alanis O, Garza-Ocanas L, Bernal MA, Pineyro-Lopez 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. doi: 10.1081/clt-100102382.

    PMID: 11192456BACKGROUND

Study Officials

  • Anne-Michelle Ruha, M.D.

    Banner Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2010

First Posted

February 1, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

June 22, 2011

Record last verified: 2011-05

Locations

US(1)