Study of T3 for the Treatment of Fibromyalgia

NCT00903877 | Completed Results

• 2 other identifiers: SU-04272009-241916295
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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).

  12 weeks

Study Arms (1)

Placebo followed by T3

EXPERIMENTAL

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.

Drug: T3

Interventions

T3 DRUG

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

Placebo followed by T3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• diabetes
• smoking
• Known uncontrolled hypertension
• known uncontrolled hypercholesterolemia

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Triiodothyronine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thyronines; Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Thyroxine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Sean Mackey, Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab
• Organization: Stanford University

smackey@stanford.edu

(650) 498-6477

Study Officials

• Ian R Carroll

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 15, 2009
• First Posted: May 19, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 14, 2017
• Results First Posted: July 14, 2017

Record last verified: 2017-06

Locations

US (1)