A Randomized Trial of Oral Iron Therapy in Fibromyalgia

NCT01820052 | Completed Phase 3

• 1 other identifier: 2013-03-DM-67
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fibromyalgia

Outcome Measures

Primary Outcomes (3)

• Widespread Pain Index

  Patient reported Widespread Pain Index (WPI)

  Change from baseline to 3 months

• Symptom Severity Scale score

  Patient reported Symptom Severity Scale score

  Change from baseline to 3 months

• Hindi version of Fibromyalgia Impact Questionnaire

  Patient reported Hindi version of Fibromyalgia Impact Questionnaire

  Change from baseline to 3 months

Secondary Outcomes (3)

• Visual Analog Scale for pain

  Change from baseline to 3 months

• Hindi version of Brief Physical Health Questionnaire

  Change from baseline to 3 months

• Hindi version of SF-36 questionnaire.

  Change from baseline to 3 months

Study Arms (2)

Oral Iron

ACTIVE COMPARATOR

Patient will receive 230 mg of oral elemental iron daily for 3 months

Drug: Oral Iron

Oral Placebo

PLACEBO COMPARATOR

Oral Placebo tablets will be administered daily for 3 months

Drug: Oral Placebo

Interventions

Oral Iron DRUG

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

Also known as: Drug

Oral Iron

Oral Placebo DRUG

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

Also known as: Placebo

Oral Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanjay Gandhi Postgraduate Institute of Medical Sciences: lead

Study Sites (1)

SGPGIMS

Lucknow, Uttar Pradesh, 226014, India

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Iron; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Vikas Agarwal, MD, DM

  Additional Professor, Clinical Immunology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: March 28, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 20, 2018

Record last verified: 2018-04

Locations

IN (1)