Treatment of Chronic Fatigue Syndrome (CFS) With Iodinated Activated Charcoal (IodoCarb®)

Phase

1/2

Condition

Chronic Fatigue Syndrome

Pain (Pediatric)

Fibromyalgia

Treatment

N/A

Clinical Study ID

NCT01793415

PL1201

Ages 35-60
All Genders

Study Summary

Chronic fatigue syndrome (CFS) is a devastating and complex disorder. People with CFS experience overwhelming fatigue and a host of other symptoms that are not improved by bed rest. Interestingly, many of the symptoms experienced by people with CFS are identical to symptoms caused by long-term low-level exposure to mercury, which is called micromercurialism.

This study will examine if the mercury binding substance IodoCarb(r) can improve the health of patients with CFS.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Chronic fatigue syndrome
35-60 years old
Male
Female (not pregnant or breastfeeding, using adequate highly effective contraceptionconsistently and correctly or >1 year post-menopausal or surgically sterile).

Exclusion

Exclusion Criteria:

Iodine allergy
abnormal thyroid function or other thyroid disease such as goiter
severely reduced kidney function (Cystatin C > 1.5 mg/L)
alcohol/drug abuse
severe depression
severe fibromyalgia
severe cardio-vascular disease
other severe disease, according to the clinical investigator
participation in another ongoing clinical trial
participation in drug trial the preceding 3 months

Study Design

February 01, 2013

December 31, 2013

Study Description

Chronic fatigue syndrome (CFS, which is also sometimes called ME, Myalgic Encephalomyelitis) is a devastating and complex disorder. People with CFS experience overwhelming fatigue and a host of other symptoms that are not improved by bed rest and that can get worse after physical activity and mental exertion. They often function at a substantially lower level of activity than they were capable of before they became ill. Besides severe fatigue, other symptoms include muscle- and joint pain, impaired memory or mental concentration, insomnia, and post-exertion malaise lasting more than 24 hours. Often, CFS can persist for many years. Researchers have not yet identified what causes CFS, and there are no specific tests to diagnose CFS. The prevalence has been suggested to be around 1-2 %.

All humans are exposed to small amounts of mercury every day from the environment. It is well-known that exposure to mercury in small quantities for a long time can affect the psychic function, and cause severe fatigue, insomnia, lack of concentration and memory problems, which is called micromercurialism. It is also known that the sensitivity to the toxic effects by mercury differs greatly between people. Thus, it is quite possible that the small amount of mercury that humans are exposed to daily are sufficient to lead to micromercurialism symptoms in sensitive individuals. Therefore, the question arises if a reduction of the mercury content in the body of CFS patients can improve their symptoms and problems in daily life.