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A Randomized Trial of Oral Iron Therapy in Fibromyalgia

NCT01820052 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-04-20

No results posted yet for this study

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 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 .

Conditions

  • Primary Fibromyalgia

Interventions

DRUG

Oral Iron

230 mg of elemental oral iron tablets will be administered daily for 3 months

DRUG

Oral Placebo

Oral tablets matching oral iron will be administered daily for 3 months

Sponsors & Collaborators

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    lead OTHER_GOV

Principal Investigators

  • Vikas Agarwal, MD, DM · Additional Professor, Clinical Immunology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-05-31
Completion
2015-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01820052 on ClinicalTrials.gov