Efficacy of N,N'bis-(2-mercaptoethyl) isophthalamide on mercury intoxication: a randomized controlled trial
- 1. Institute and Outpatient Clinic for Occupational, Social and Environmental Medicine, WHO Collaborating Centre for Occupational Health, University Hospital Munich, Ziemssenstr. 1, D-80336, Munich, Germany. paul.schutzmeier@med.uni-muenchen.de.
- 2. FOMAT Medical Research, Oxnard, CA, USA.
- 3. Institute and Outpatient Clinic for Occupational, Social and Environmental Medicine, WHO Collaborating Centre for Occupational Health, University Hospital Munich, Ziemssenstr. 1, D-80336, Munich, Germany. Institute of Public Health, Medical Decision Making and Health Technology Assessment, Department of Public Health, Health Services Research and Health Technology Assessment, UMIT (University for Health Sciences, Medical Informatics and Technology), A-6060 Hall i.T, Innsbruck, Austria.
Description
BACKGROUND:
Chronic mercury intoxication is a severe health issue and occurs especially in gold mining communities. Common chelators used for improving mercury elimination are not everywhere available and challenged by poor cell wall penetration. This study is part of a feasibility trial and the aim was to gather first information about the efficacy of the newly developed chelator N,N'bis-(2-mercaptoethyl) isophthalamide (NBMI) on chronic mercury intoxication.
METHODS:
In this three-armed, placebo-controlled randomized trial, 36 miners with mercury urine levels exceeding 15 μg/l were administered 100 mg NBMI, 300 mg NBMI or placebo for 14 days. Levels of mercury in urine [μg/l and μg/g creatinine] and plasma l were analyzed. Therapeutic effect was assessed using the medical intoxication score (MIS) and its single health outcomes (e.g. excessive salivation, sleeping problems), fatigue scores, a neuromotoric test battery (CATSYS) and a neurological outcome (Finger to nose test).
RESULTS:
Physical fatigue was significantly decreased in the 300 mg NBMI group compared to the control. Mercury concentration in urine following 300 mg NBMI treatment was significantly lowered compared to control, however, this effect was less distinct with adjustment for creatinine.
CONCLUSION:
NBMI showed an effect on physical fatigue and there were indications to positive effects on other symptoms as well. More comprehensive studies are mandatory to verify the effects of NBMI as a novel tool for treating mercury intoxications.
TRIAL REGISTRATION:
ClinicalTrials.gov Identifier: NCT02486289 . Date of registration: June 24, 2015.
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