Autoimmune Thyroiditis Clinical Trial
Official title:
Low-Level Laser Therapy in Chronic Autoimmune Thyroiditis: Randomized, Placebo Controlled Clinical Trial
The purpose of this study is to evaluate whether low-level Laser therapy is effective in ameliorating the thyroid function of patients with hypothyroidism caused by chronic autoimmune thyroiditis.
Status | Completed |
Enrollment | 43 |
Est. completion date | March 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Patients previously diagnosed with hypothyroidism induced by chronic autoimmune thyroiditis (CAT). The presence of hypothyroidism, laboratory measurements and ultrasonography criteria were applied to diagnose CAT. - Significantly elevated concentrations of thyroid peroxidase (TPOAb) and/or thyroglobulin (TgAb) autoantibodies - Ultrasonography results consistent with CAT - Patients undergoing LT4 treatment - Normal (or almost normal) levels of triiodothyronine (T3), thyroxine (T4), free T4 and thyrotropin (TSH) Exclusion Criteria: - Use of immunosuppressants, immunostimulants, or other drugs that could interfere with the production, metabolism and transport of thyroid hormones - CAT with normal thyroid function - CAT with subclinical hypothyroidism - Thyroid nodules - Hypothyroidism stemming from post-partum thyroiditis (up to 18 months after gestation) - History of Graves' disease - Thyrotropin receptor antibody (TRAb) detectable - Prior treatment with radioiodine - Tracheal stenosis - Pregnancy - History of ionizing irradiation and/or neoplasia in the cervical area - Previous surgical intervention in the thyroid - Thyroid hypoplasia - Ectopic thyroid - Serious illness (cancer, ischemic coronary artery disease, stroke, kidney or liver failure, etc.) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | University of Sao Paulo General Hospital | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital | Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do Estado de São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The main outcome measure was to gauge the effectiveness of applying LLLT in patients with hypothyroidism caused by CAT evaluated by a significant reduction of the levothyroxine (LT4) mean dose (µ/day) 9 months post-LT4 withdrawal. | All patients enrolled in the study were undergoing LT4 treatment. They received 10 applications of LLLT or placebo. Thirty days after intervention, LT4 was discontinued in all patients and, if required, reintroduced. T3, T4, free T4 and TSH levels (all laboratory personnel was blinded), were assessed pre-LLLT and then 1, 2, 3, 6 and 9 months post-LT4 withdrawal. The LT4 mean dose pre-LLLT and 9 months post-LT4 withdrawal was compared both in face of normal levels of T3, T4, free T4 and TSH to evaluate LLLT effectiveness. | LT4 dose, concentrations of T3, T4, free T4 and TSH were evaluated and compared before intervention and 9 months post-LT4 withdrawal. | Yes |
Secondary | Evaluate the LLLT efficacy in reducing thyroid autoantibodies concentrations. | Thyroid peroxidase (TPOAb) and thyroglobulin (TgAb) autoantibodies were both determined prior to LLLT and in the 1st, 2nd, 3rd, 6th and 9th months after LT4 withdrawal. All laboratory personnel was blinded to treatment assignment throughout the study. | Thyroid autoantibodies were determined and compared pre-intervention and 9 months post-LT4 withdrawal. | Yes |
Secondary | Evaluate the LLLT efficacy by quantitative and qualitative ultrasonography parameters. | B-mode sonography (volume, texture and echogenicity using computerized histogram) as well as power Doppler (vascularization) and pulsed Doppler (maximal systolic peak velocity and resistance index for the thyroid arteries) were performed and compared pre- and 30 days post-intervention by only one experienced and blind investigator, during the use of the same doses of LT4. | The ultrasonography parameters observed pre-LLLT were compared with those observed 30 days post-LLLT. | Yes |
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