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Study of T3 for the Treatment of Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
T3
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Placebo followed by T3

Arm 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.

Outcomes

Primary Outcome Measures

Visual Analogue Scale of Pain Intensity
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).

Secondary Outcome Measures

Full Information

First Posted
May 15, 2009
Last Updated
June 15, 2017
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT00903877
Brief Title
Study of T3 for the Treatment of Fibromyalgia
Official Title
T3 for Fibromyalgia: a Pilot Double-blind Non-randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo followed by T3
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
T3
Intervention Description
Patients receive T3 in a dose of 25mcg and 50mcg
Primary Outcome Measure Information:
Title
Visual Analogue Scale of Pain Intensity
Description
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).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-50 Meet american college of rheumatology criteria for fibromyalgia at baseline report an average pain of 4 or more on a brief Pain Inventory. can climb 2 flights of stairs without shortness of breath. Exclusion Criteria: new medication change in the last 2 months any cardiac disease at all known thyroid disease before or after thyroid screening bloodwork unstable medical or psychiatric disease. Known inflammatory or rheumatic disease other than fibromyalgia substance abuse in the last year suicidality or depression as indicated by a Beck Depression Inventory of 30 or above concomitant herbal medications multiple severe medication allergies the assessment of the research team that inclusion of the subject could in some way compromise the safety and validity of the study. diabetes smoking Known uncontrolled hypertension known uncontrolled hypercholesterolemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian R Carroll
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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Study of T3 for the Treatment of Fibromyalgia

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