Trial record 11 of 112 for:    fibromyalgia | Open Studies | Interventional Studies

A Randomized Trial of Oral Iron Therapy in Fibromyalgia

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
  Purpose

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 .


Condition Intervention Phase
Primary Fibromyalgia
Drug: Oral Iron
Drug: Oral Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind , Randomized, Placebo-controlled Trial of Oral Iron Therapy in Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Sanjay Gandhi Postgraduate Institute of Medical Sciences:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral Iron
Patient will receive 230 mg of oral elemental iron daily for 3 months
Drug: Oral Iron
230 mg of elemental oral iron tablets will be administered daily for 3 months
Other Name: Drug
Placebo Comparator: Oral Placebo
Oral Placebo tablets will be administered daily for 3 months
Drug: Oral Placebo
Oral tablets matching oral iron will be administered daily for 3 months
Other Name: Placebo

Detailed Description:

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 .

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01820052

Contacts
Contact: Vikas Agarwal, MD, DM 915222494318 vikasagr@sgpgi.ac.in
Contact: Durga P Misra, MD 918004904395 durgapmisra@gmail.com

Locations
India
SGPGIMS Not yet recruiting
Lucknow, UP, India, 226014
Contact: Vikas Agarwal, MD, DM    915222494318    vikasagr@sgpgi.ac.in   
Contact: Durga P Misra, MD    918004904395    durgapmisra@gmail.com   
Principal Investigator: Vikas Agarwal, MD, DM         
Sponsors and Collaborators
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Investigators
Principal Investigator: Vikas Agarwal, MD, DM Additional Professor, Clinical Immunology
  More Information

No publications provided

Responsible Party: Sanjay Gandhi Postgraduate Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT01820052     History of Changes
Other Study ID Numbers: 2013-03-DM-67
Study First Received: March 21, 2013
Last Updated: April 1, 2013
Health Authority: India: Ministry of Health

Keywords provided by Sanjay Gandhi Postgraduate Institute of Medical Sciences:
Fibromyalgia

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014