Study of T3 for the Treatment of Fibromyalgia

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Drug: T3

• Registration Number: NCT00903877
• Lead Sponsor: Stanford University

Brief Summary

Determine if T3 - the active form of thyroid hormone - is beneficial in fibromyalgia. Determine the feasibility and promise of an appropriately powered future prospective randomized controlled study of using T3 (the active form of thyroid hormone) for the treatment of fibromyalgia. We specifically aim to assess the feasibility, cost, obstacles and promise of conducting a prospective controlled study in the future.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-15
• Study First Submitted QC: 2009-05-18
• Study First Posted: 2009-05-19
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2017-04-03
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-15
• Last Update Submitted: 2017-06-15
• Results First Posted: 2017-07-14
• Last Update Posted: 2017-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

1. Age 18-50
2. Meet american college of rheumatology criteria for fibromyalgia
3. at baseline report an average pain of 4 or more on a brief Pain Inventory.
4. can climb 2 flights of stairs without shortness of breath.

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Exclusion Criteria

1. new medication change in the last 2 months
2. any cardiac disease at all
3. known thyroid disease before or after thyroid screening bloodwork
4. unstable medical or psychiatric disease.
5. Known inflammatory or rheumatic disease other than fibromyalgia
6. substance abuse in the last year
7. suicidality or depression as indicated by a Beck Depression Inventory of 30 or above
8. concomitant herbal medications
9. multiple severe medication allergies
10. the assessment of the research team that inclusion of the subject could in some way compromise the safety and validity of the study.
11. diabetes
12. smoking
13. Known uncontrolled hypertension
14. known uncontrolled hypercholesterolemia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo followed by T3	T3	Participants receive placebo for 4 weeks. Following placebo, participants begin T3 treatment at 25 mcg per day, for 4 weeks. Following this, participants begin T3 treatment at 50 mcg per day, for 4 more weeks.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale of Pain Intensity	12 weeks	Patients rated their pain at baseline, placebo, T3 at 25 mcg, and T3 at 50 mcg. The scale ranged from 0 (no pain) to 10 (pain as bad as it can be).

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States