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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Fatigue Syndrome
• Intervention / Treatment: Drug: IodoCarb (r); Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, SE-222 22
    • Recruiting
    • ProbarE i Lund AB
    • Contact: Ewa Karlsson; Phone Number: +46 732 300 450; Email: ewa.karlsson@probare.se
    • Principal Investigator: Anders Luts, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IodoCarb (r); 3 g iodinated activated charcoal, IodoCarb(r), daily for 28 +-2 days.	Drug: IodoCarb (r); Powder, 3 grams daily for 28+-2 days
Placebo Comparator: Placebo; 3 g of non-iodinated activated charcoal daily for 28+-2 days.	Other: Placebo; Non-iodinated activated charcoal 3 g daily for 28+-2 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life questionnaire score	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of psychotropic drugs	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.	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.
Physical activity measured by a pedometer	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.	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.

Collaborators and Investigators

• Sponsor: PharmaLundensis AB
• Investigators: Principal Investigator: Anders Luts, MD, PhD, ProbarE i Lund AB

Publications and helpful links

Helpful Links

• The sponsor´s web site (in swedish)

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: February 7, 2013
• First Submitted That Met QC Criteria: February 14, 2013
• First Posted (Estimate): February 15, 2013

Study Record Updates

• Last Update Posted (Estimate): February 15, 2013
• Last Update Submitted That Met QC Criteria: February 14, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Syndrome; Fatigue; Fatigue Syndrome, Chronic
• Other Study ID Numbers: PL1201