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

NCT ID: NCT01793415

Last Updated: 2013-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-12-31

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.

Conditions

Chronic Fatigue Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IodoCarb (r)

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

Group Type: ACTIVE_COMPARATOR

IodoCarb (r)

Intervention Type: DRUG

Powder, 3 grams daily for 28+-2 days

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Non-iodinated activated charcoal 3 g daily for 28+-2 days

Interventions

IodoCarb (r)

Powder, 3 grams daily for 28+-2 days

Intervention Type: DRUG

Placebo

Non-iodinated activated charcoal 3 g daily for 28+-2 days

Intervention Type: OTHER

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PharmaLundensis AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders Luts, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Probare i Lund AB

Locations

Probare i Lund AB

Lund, , Sweden

Site Status: RECRUITING

Countries

Sweden

Facility Contacts

Ewa Karlsson

Role: primary

ewa.karlsson@probare.se

+46 732 300 450

Related Links

http://www.pharmalundensis.se/

The sponsor´s web site (in swedish)

Other Identifiers

PL1201

Identifier Type: -

Identifier Source: org_study_id