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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by PharmaLundensis AB
Sponsor:
Information provided by (Responsible Party):
PharmaLundensis AB
ClinicalTrials.gov Identifier:
NCT01793415
First received: February 7, 2013
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Chronic Fatigue Syndrome
Drug: IodoCarb (r)
Other: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 1 + 2a Proof of Concept Study of Treatment of Chronic Fatigue Syndrome (CFS) With Iodinated Activated Charcoal (IodoCarb®)

Resource links provided by NLM:


Further study details as provided by PharmaLundensis AB:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: February 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   35 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01793415

Locations
Sweden
Probare i Lund AB Recruiting
Lund, Sweden, SE-222 22
Contact: Ewa Karlsson    +46 732 300 450    ewa.karlsson@probare.se   
Principal Investigator: Anders Luts, MD, PhD         
Sponsors and Collaborators
PharmaLundensis AB
Investigators
Principal Investigator: Anders Luts, MD, PhD Probare i Lund AB
  More Information

Additional Information:
No publications provided

Responsible Party: PharmaLundensis AB
ClinicalTrials.gov Identifier: NCT01793415     History of Changes
Other Study ID Numbers: PL1201
Study First Received: February 7, 2013
Last Updated: February 14, 2013
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Fatigue Syndrome, Chronic
Fatigue
Syndrome
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Disease
Pathologic Processes
Charcoal
Antidotes
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014