Transdermal Absorption of DMPS and Its Effect on Urinary Mercury Excretion
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- serum DMPS level
研究概览
简要总结
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.
详细描述
I. Background Information and Literature:
2,3-dimercaptopropane-1-sulfonate (DMPS) is a chelating agent that has been used for years in Europe for treatment of poisoning by metals such as mercury, arsenic, and lead. It is a water soluble analog of dimercaptopropanol (British anti-Lewisite, or BAL), which is an FDA approved chelating agent administered via deep intramuscular injection. DMPS is not FDA approved, but is approved in Europe and is available in Germany without a prescription, as Dimaval. It is felt to have less toxicity than BAL, and unlike BAL, is effective when administered orally(1).
A comprehensive review by Aposhian, et al (1) notes that DMPS has been studied since the late 1950's in the Soviet Union and China and appears innocuous. This review mentions a 1979 study which followed 168 scleroderma patients receiving DMPS for 10 years. Some patients experienced mild side effects such as minor allergic reaction (26 patients, none with anaphylaxis), nausea (11 patients), vertigo (7 patients), weakness (4 patients), or itching (3 patients). No renal toxicity was noted. Additionally, chelation therapy with oral DMPS was found to be safe when used in a series of patients with methylmercury toxicity from contaminated grain in Iraq in 1972 (2). It was also not associated with any adverse effects when used to orally chelate lead poisoned children in Baltimore, Maryland in 1985 (3). This 1985 study cites case series of DMPS being safely and effectively used for treatment of lead poisoning and inorganic mercury poisoning as well.
DMPS showed no mutagenicity in the Ames salmonella microsome plate test.
Soviet studies showed that when their usual human dose of 5mg/kg IV was increased to 100mg/kg IV, ulceration or necrosis at the injection site was noted. Animal studies with very large (50mg/kg) IV doses showed tremors, tachycardia, dyspnea, vomiting, and defecation. Other animal studies, however, noted no behavioral, weight, or blood composition changes in animals given 15 or 80mg/kg IV DMPS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult
排除标准
- •Under 18 years of age
- •Allergy to sulfa
- •Eat less than three fish servings per week
研究组 & 干预措施
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.
干预措施: transdermal DMPS (Drug)
结局指标
主要结局
serum DMPS level
时间窗: within 6 hours of application
次要结局
- change in urinary mercury excretion(12 hours preceeding and following DMPS)