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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase 1 + 2a Proof of Concept Study of Treatment of Chronic Fatigue Syndrome (CFS) With Iodinated Activated Charcoal (IodoCarb®)

Brief 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.


Detailed Summary:

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.

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

This is a double blind placebo controlled parallel group study.

Patient population: 40 patients diagnosed with
Sponsor: PharmaLundensis AB

Current Primary Outcome: Quality of life questionnaire score [ Time Frame: The QoL score during the last (fourth) treatment week is compared to the QoL score during the control week just prior to the treatment period. ]

The QoL score during the last (fourth) treatment week is compared to the QoL score during the control week just prior to the treatment period. Results from patients receiving active substance will be compared to patients who received placebo.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Use of psychotropic drugs [ Time Frame: The intake of psychotropic drugs during the last (fourth) treatment week is compared to the intake during the control week just prior to the treatment period. ]
    The intake of psychotropic drugs (sedatives, anxiolytics or hypnotic drugs) during the last (fourth) treatment week is compared to the intake of psychotropic drugs during the control week just prior to the treatment period. Results from the IodoCarb group will be compared to results from the Placebo group.
  • Physical activity measured by a pedometer [ Time Frame: The physical activity of patients during the last (fourth) treatment week is compared to the physical activity during the control week just prior to the treatment period. ]
    The physical activity of patients during the last (fourth) treatment week is compared to the physical activity during the control week just prior to the treatment period using a pedometer. Results from the IodoCarb group will be compared to results from the Placebo group.


Original Secondary Outcome: Same as current

Information By: PharmaLundensis AB

Dates:
Date Received: February 7, 2013
Date Started: February 2013
Date Completion: December 2013
Last Updated: February 14, 2013
Last Verified: February 2013