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

NCT01793415 | Unknown Phase 1

• 1 other identifier: PL1201
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Use of psychotropic drugs

  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.

Study Arms (2)

IodoCarb (r)

ACTIVE COMPARATOR

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

Drug: IodoCarb (r)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

IodoCarb (r) DRUG

Powder, 3 grams daily for 28+-2 days

IodoCarb (r)

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chronic fatigue syndrome
• years old
• Male
• Female (not pregnant or breastfeeding, using adequate highly effective contraception consistently and correctly or \>1 year post-menopausal or surgically sterile).

You may not qualify if:

• 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

Sponsors & Collaborators

• PharmaLundensis AB: lead

Study Sites (1)

Probare i Lund AB

Lund, SE-222 22, Sweden

RECRUITING

Related Links

• The sponsor´s web site (in swedish)

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anders Luts, MD, PhD

  Probare i Lund AB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 15, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

SE (1)