A Randomized Trial of Oral Iron Therapy in Fibromyalgia

This study is not yet open for participant recruitment.
Verified March 2013 by Sanjay Gandhi Postgraduate Institute of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Sanjay Gandhi Postgraduate Institute of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01820052
First received: March 21, 2013
Last updated: April 1, 2013
Last verified: March 2013

March 21, 2013
April 1, 2013
April 2013
May 2014   (final data collection date for primary outcome measure)
  • Widespread Pain Index [ Time Frame: Change from baseline to 3 months ] [ Designated as safety issue: No ]
    Patient reported Widespread Pain Index (WPI)
  • Symptom Severity Scale score [ Time Frame: Change from baseline to 3 months ] [ Designated as safety issue: No ]
    Patient reported Symptom Severity Scale score
  • Hindi version of Fibromyalgia Impact Questionnaire [ Time Frame: Change from baseline to 3 months ] [ Designated as safety issue: No ]
    Patient reported Hindi version of Fibromyalgia Impact Questionnaire
Same as current
Complete list of historical versions of study NCT01820052 on ClinicalTrials.gov Archive Site
  • Visual Analog Scale for pain [ Time Frame: Change from baseline to 3 months ] [ Designated as safety issue: No ]
    Patient reported Visual Analog Scale for pain on a 10 cm scale
  • Hindi version of Brief Physical Health Questionnaire [ Time Frame: Change from baseline to 3 months ] [ Designated as safety issue: No ]
    Patient reported Hindi version of Brief Physical Health Questionnaire
  • Hindi version of SF-36 questionnaire. [ Time Frame: Change from baseline to 3 months ] [ Designated as safety issue: No ]
    Patient reported Hindi version of SF-36 questionnaire.
Same as current
Not Provided
Not Provided
 
A Randomized Trial of Oral Iron Therapy in Fibromyalgia
A Double-blind , Randomized, Placebo-controlled Trial of Oral Iron Therapy in Fibromyalgia

Fibromyalgia (FM) is a disorder with chronic widespread musculoskeletal pain for which no alternative cause can be identified. The condition is often accompanied by other features such as fatigue, stiffness, cold intolerance, cognitive impairment, intolerance to external stimuli, sleep disturbances, anxiety and depression, which significantly affect the quality of life. Fibromyalgia is characterized by altered pain perception, and studies have shown fibromyalgia to be more prevalent in patients with iron deficiency anemia. Iron is essential for a number of enzymes involved in serotonin and dopamine synthesis. Deficiency of serotonergic neuronal functioning might be related to the pathophysiology of FM.

This study attempts to explore the use of oral iron as a cheap and readily available alternative for the treatment of FM .

Fibromyalgia (FM) is a disorder with chronic widespread musculoskeletal pain for which no alternative cause can be identified . The condition is often accompanied by other features such as fatigue, stiffness, cold intolerance, cognitive impairment, intolerance to external stimuli, sleep disturbances, anxiety and depression, which significantly affect the quality of life. Fibromyalgia is characterized by altered pain perception, and studies have shown fibromyalgia to be more prevalent in patients with iron deficiency anemia. Iron is essential for a number of enzymes involved in serotonin and dopamine synthesis. Deficiency of serotonergic neuronal functioning might be related to the pathophysiology of FM. A dysregulation of dopaminergic transmission in the pathophysiology of FM has also been suggested. This has brought forth the postulation that iron as a cofactor in serotonin and dopamine production may have a role in the etiology of FM.

A number of therapies are currently in vogue for FM, both pharmacological and non-pharmacological. Drugs shown to be effective in FM include tricyclic antidepressants(amitryptiline, cyclobenzaprine), dual reuptake inhibitors (duloxetine, milnacipran) and alpha-2-delta ligands (pregabalin, gabapentin). However cost is a major factor, and often treatment results are disappointing . Hence the investigators planned to conduct a randomized controlled trial of iron therapy in fibromyalgia . IF proven, iron could be a cheap and easily available alternative for the treatment of this common and often disabling condition.

Materials and methods:

Patients with FM attending the OPD of the Department of Clinical Immunology will be identified . Diagnosis shall be made as per the ACR 2010 preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. After seeking informed consent, the subjects will undergo baseline investigation to look for Hb, thyroid function tests and 25-OH-Vitamin. Patients with a Hb<8 g or having hypothyroidism , deficiency of Vitamin D or any connective tissue disease will be excluded from the study. Patients with a baseline FIQ >40 will be taken up for study. Baseline depression will be assessed using BPHQ and patients with a baseline BPHQ > 4 will be excluded from study. Following this, the patients will undergo assessment of serum ferritin at baseline, and irrespective of serum ferritin levels, will be randomized into 2 groups. Target sample size in each group will be 60. The groups will be blinded from both the patients and the investigators, and allocation concealment will be maintained by use of pre-sealed envelopes and drug packets. Group A will receive standard of care treatment for fibromyalgia (Amitryptiline up to 25 mg/day, Duloxetine upto 60 mg/day, Pregabalin upto 300 mg/day either singly or in combination) along with placebo for 3 months. Group B will receive standard of care treatment for fibromyalgia (Amitryptiline upto 25 mg/day, Duloxetine upto 60 mg/day, Pregabalin up to 300 mg/day either singly or in combination) along with 230 mg of oral elemental iron daily for 3 months. Assessment at baseline and at 3 months will be done with respect to the primary end points - Widespread Pain Index (WPI), Symptom Severity Scale score (SSS), Hindi version of Fibromyalgia Impact Questionnaire (FIQ) , and secondary end points - Visual Analog Scale for pain (VAS) , Hindi version of Brief Physical Health Questionnaire (BPHQ) , Hindi version of SF-36 questionnaire. Patients will be monitored for side effects of oral iron therapy ( nausea,vomiting, gastrointestinal irritation , constipation , diarrhea) . At the end of 3 months, statistical analysis will be done to determine significance of difference between placebo groups A and B with respect to the above mentioned end points. Patients with a change in FIQ > 25% will be taken as responders. The change in levels of various end points before and after, viz. WPI, SSS, VAS, BPHQ, SF-36 will be a secondary consideration.

Significance:

This study attempts to explore the use of oral iron as a cheap and readily available alternative for the treatment of FM .

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Primary Fibromyalgia
  • Drug: Oral Iron
    230 mg of elemental oral iron tablets will be administered daily for 3 months
    Other Name: Drug
  • Drug: Oral Placebo
    Oral tablets matching oral iron will be administered daily for 3 months
    Other Name: Placebo
  • Active Comparator: Oral Iron
    Patient will receive 230 mg of oral elemental iron daily for 3 months
    Intervention: Drug: Oral Iron
  • Placebo Comparator: Oral Placebo
    Oral Placebo tablets will be administered daily for 3 months
    Intervention: Drug: Oral Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
120
December 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients of Fibromyalgia fulfilling ACR 2010 criteria.
  • Patients with a baseline FIQ >40 will be taken up for study.

Exclusion Criteria:

  • Patients with a Hb<8 g or having hypothyroidism , deficiency of Vitamin D or any connective tissue disease will be excluded from the study.
  • Baseline depression will be assessed using BPHQ and patients with a baseline BPHQ > 4 will be excluded from study.
Both
18 Years to 70 Years
No
Contact: Vikas Agarwal, MD, DM 915222494318 vikasagr@sgpgi.ac.in
Contact: Durga P Misra, MD 918004904395 durgapmisra@gmail.com
India
 
NCT01820052
2013-03-DM-67
No
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Not Provided
Principal Investigator: Vikas Agarwal, MD, DM Additional Professor, Clinical Immunology
Sanjay Gandhi Postgraduate Institute of Medical Sciences
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP