Clinical trial NCT01793415: Treatment of Chronic Fatigue Syndrome (CFS) With Iodinated Activated Charcoal (IodoCarb®)
Official title: Phase 1 + 2a Proof of Concept Study of Treatment of Chronic Fatigue Syndrome (CFS) With Iodinated Activated Charcoal (IodoCarb®)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Chronic Fatigue Syndrome
Lead sponsor: PharmaLundensis AB
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 CFS will participate.

Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Quality of life questionnaire score
timeFrame: 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.
Secondary outcomes:
measure: Use of psychotropic drugs
timeFrame: 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.
measure: Physical activity measured by a pedometer
timeFrame: 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.
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Probare i Lund AB
Study officials:
affiliation: Probare i Lund AB
name: Anders Luts, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: