Study of T3 for the Treatment of Fibromyalgia

Stanford University

Status: Completed

Conditions: Fibromyalgia

Treatments: Drug: T3

Study type: Interventional

Funder types: Other

Identifiers

NCT00903877

16295

SU-04272009-2419

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Placebo followed by T3

Experimental group

Description:

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.

Treatment:

Drug: T3