Primary FibromyalgiaPhase 3NCT01820052
A Randomized Trial of Oral Iron Therapy in Fibromyalgia
A Phase 3 study testing Oral Iron in people with Primary Fibromyalgia, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 1 site in India.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Fibromyalgia
- What is being tested?
- Oral Iron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2013to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of Fibromyalgia fulfilling ACR 2010 criteria.
- Patients with a baseline FIQ >40 will be taken up for study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
Read the 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 .
- Conditions
- Primary Fibromyalgia
- Being tested
- Oral Iron, Oral Placebo
- Keywords
- Fibromyalgia
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral IronDrug
Also called Drug
230 mg of elemental oral iron tablets will be administered daily for 3 months
Oral PlaceboDrug
Also called Placebo
Oral tablets matching oral iron will be administered daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Oral Iron | Active comparator | Patient will receive 230 mg of oral elemental iron daily for 3 months Receives: Drug: Oral Iron |
| Oral Placebo | Placebo comparator | Oral Placebo tablets will be administered daily for 3 months Receives: Drug: Oral Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Widespread Pain Index
Patient reported Widespread Pain Index (WPI)
Measured: Change from baseline to 3 months
Symptom Severity Scale score
Patient reported Symptom Severity Scale score
Measured: Change from baseline to 3 months
Hindi version of Fibromyalgia Impact Questionnaire
Patient reported Hindi version of Fibromyalgia Impact Questionnaire
Measured: Change from baseline to 3 months
Secondary outcomes (3)
Visual Analog Scale for pain
Patient reported Visual Analog Scale for pain on a 10 cm scale
Measured: Change from baseline to 3 months
Hindi version of Brief Physical Health Questionnaire
Patient reported Hindi version of Brief Physical Health Questionnaire
Measured: Change from baseline to 3 months
Hindi version of SF-36 questionnaire.
Patient reported Hindi version of SF-36 questionnaire.
Measured: Change from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Vikas Agarwal, MD, DM, Principal investigator, Additional Professor, Clinical Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820052
- Sponsor's protocol ID
- 2013-03-DM-67
- Status last verified
- Apr 2018
- First submitted
- 21 Mar 2013
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind , Randomized, Placebo-controlled Trial of Oral Iron Therapy in Fibromyalgia
- ClinicalTrials.gov ID
- NCT01820052
- Acronym / sponsor ID
- 2013-03-DM-67
- Conditions
- Primary Fibromyalgia
- Keywords
- Fibromyalgia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical SciencesOther government
- Study start
- Apr 2013 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Iron | Active comparator | Drug: Oral IronPatient will receive 230 mg of oral elemental iron daily for 3 months |
| Oral Placebo | Placebo comparator | Drug: Oral PlaceboOral Placebo tablets will be administered daily for 3 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of Fibromyalgia fulfilling ACR 2010 criteria.
- Patients with a baseline FIQ >40 will be taken up for study.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral IronAlso: Drug230 mg of elemental oral iron tablets will be administered daily for 3 months | Drug | Oral Iron |
| Oral PlaceboAlso: PlaceboOral tablets matching oral iron will be administered daily for 3 months | Drug | Oral Placebo |
Primary outcome
Widespread Pain Index
Time frame: Change from baseline to 3 months
Patient reported Widespread Pain Index (WPI)
Symptom Severity Scale score
Time frame: Change from baseline to 3 months
Patient reported Symptom Severity Scale score
Hindi version of Fibromyalgia Impact Questionnaire
Time frame: Change from baseline to 3 months
Patient reported Hindi version of Fibromyalgia Impact Questionnaire
3 secondary outcomes
Visual Analog Scale for pain
Time frame: Change from baseline to 3 months
Hindi version of Brief Physical Health Questionnaire
Time frame: Change from baseline to 3 months
Hindi version of SF-36 questionnaire.
Time frame: Change from baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
Related trials for Primary Fibromyalgia
Not yet recruiting
Feasibility and Preliminary Effects of an Asynchronous Microlearning Intervention on Fibromyalgia Knowledge Among Primary Health Care Workers
Fibromyalgia, Fibromyalgia (FM)
Not yet recruitingObservational study
The Precision Mito- Mito Map COMPASS Study
Mitochondrial Diseases, Myalgic Encephalomyelitis Chronic Fatigue Syndrome
Not yet recruiting
Hyperthermia in Patients With Chronic Primary Pain - Effects on Thermoregulation, Somatosensory System and Movement Evoked Pain
Hyperthermia, Chronic Primary Pain
Recruiting
The Effect of Remote Electrical Neuromodulation (REN) on Conditioned Pain Modulation (CPM) in Migraine and Fibromyalgia
Migraine, Fibromyalgia
Recruiting
The Effect of Fermented Grape Juice Consumption on Fibromyalgia Patients
Fibromyalgia, Fibromyalgia (FM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vikas Agarwal, MD, DM principal investigator
Additional Professor, Clinical Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oral Iron in people with Primary Fibromyalgia, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Widespread Pain Index (time frame: Change from baseline to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.