A Randomized Trial of Oral Iron Therapy in Fibromyalgia

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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 .

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanjay Gandhi Postgraduate Institute of Medical Sciences
• Treatments: Iron

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.