Study of T3 for the Treatment of Fibromyalgia

NCT ID: NCT00903877

Last Updated: 2017-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-06-30

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Placebo followed by 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.

Group Type: EXPERIMENTAL

T3

Intervention Type: DRUG

Patients receive T3 in a dose of 25mcg and 50mcg

Interventions

T3

Patients receive T3 in a dose of 25mcg and 50mcg

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Sean Mackey

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ian R Carroll

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

16295

Identifier Type: -

Identifier Source: secondary_id

SU-04272009-2419

Identifier Type: -

Identifier Source: org_study_id