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

PharmaLundensis

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Chronic Fatigue Syndrome

Treatments: Other: Placebo; Drug: IodoCarb (r)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01793415

PL1201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 35 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

IodoCarb (r)

Active Comparator group

Description:

3 g iodinated activated charcoal, IodoCarb(r), daily for 28 +-2 days.

Treatment:

Drug: IodoCarb (r)

Placebo

Placebo Comparator group

Description:

3 g of non-iodinated activated charcoal daily for 28+-2 days.

Treatment:

Other: Placebo