Treatment of Chronic Fatigue Syndrome (CFS) With Iodinated Activated Charcoal (IodoCarb®)
Primary Purpose
Chronic Fatigue Syndrome
Status
Unknown status
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
IodoCarb (r)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Fatigue Syndrome
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
Sites / Locations
- Probare i Lund ABRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
IodoCarb (r)
Placebo
Arm Description
3 g iodinated activated charcoal, IodoCarb(r), daily for 28 +-2 days.
3 g of non-iodinated activated charcoal daily for 28+-2 days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01793415
Brief Title
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
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PharmaLundensis AB
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IodoCarb (r)
Arm Type
Active Comparator
Arm Description
3 g iodinated activated charcoal, IodoCarb(r), daily for 28 +-2 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
3 g of non-iodinated activated charcoal daily for 28+-2 days.
Intervention Type
Drug
Intervention Name(s)
IodoCarb (r)
Intervention Description
Powder, 3 grams daily for 28+-2 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Non-iodinated activated charcoal 3 g daily for 28+-2 days
Primary Outcome Measure Information:
Title
Quality of life questionnaire score
Description
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.
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.
Secondary Outcome Measure Information:
Title
Use of psychotropic drugs
Description
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.
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.
Title
Physical activity measured by a pedometer
Description
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.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Luts, MD, PhD
Organizational Affiliation
Probare i Lund AB
Official's Role
Principal Investigator
Facility Information:
Facility Name
Probare i Lund AB
City
Lund
ZIP/Postal Code
SE-222 22
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ewa Karlsson
Phone
+46 732 300 450
Email
ewa.karlsson@probare.se
First Name & Middle Initial & Last Name & Degree
Anders Luts, MD, PhD
12. IPD Sharing Statement
Links:
URL
http://www.pharmalundensis.se/
Description
The sponsor´s web site (in swedish)
Learn more about this trial
Treatment of Chronic Fatigue Syndrome (CFS) With Iodinated Activated Charcoal (IodoCarb®)
We'll reach out to this number within 24 hrs