Effect of Treatment for Vitamin D Deficiency on Thyroid Function and Autoimmunity in Hashimoto's Thyroiditis.

Study Overview
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Brief Summary
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The objective of this study is to evaluate the effect of vitamin D supplementation on thyroid autoimmunity, thyroid function, and other metabolic and clinical variables associated with the thyroid axis in patients with Hashimoto's thyroiditis and vitamin D deficiency.

Official Title
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Effect of Vitamin D Supplementation on Autoimmunity and Thyroid Function in Subjects With Hashimoto's Thyroiditis and Vitamin D Deficiency: Clinical Pilot Trial.

Conditions
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Hashimoto Disease, Treatment Levothyroxine, Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Vitamin D-correction
* Dietary Supplement: Vitamin D-RDA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women between 18-45 years old (pre-menopausal stage) men between 18-60 years old BMI between 18.5-34.9 kg/ m2 medical diagnosis of Hashimoto's thyroiditis treatment with levothyroxine (LT4) with stable dose (from four months from the start of the intervention) positive antithyroid antibody (peroxidase and/or thyroglobulin) serum 25 (OH) D levels <20 ng / ml. Exclusion Criteria: radioiodine, thyroidectomy, antithyroid treatment disease, condition or drug treatment that alters the immune system or hypothalamic-pituitary-thyroid axis or vitamin D metabolism. disorder of kidney, liver, or bone-metabolic function Graves disease, toxic nodular goiter, postpartum thyroiditis, coronary heart disease, epilepsy, cancer, Turner or Down syndrome, primary hyperparathyroidism vitamin D, calcium, complex B, omega-3 supplements pregnant or breastfeeding type 2 diabetes or dyslipidemia with drug treatment at unstable doses intense physical activity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients will randomly receive the experimental condition or the active comparator for 3 months. After 3 months of washout, the groups will be crossed to receive the opposite treatment.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D-correction<br>Subjects will receive one capsule with 50.000 IU cholecalciferol weekly for 3 months. | Dietary Supplement: Vitamin D-correction<br>* Capsule with 50.000 UI cholecalciferol<br>|
| Active Comparator: Vitamin D-RDA<br>Subjects will receive one capsule with 4.200 IU cholecalciferol weekly for 3 months. | Dietary Supplement: Vitamin D-RDA<br>* Capsule with 4.2000 UI cholecalciferol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline antithyroid antibodies at 3 months | Anti-thyroid peroxidase and anti-thyroglobulin antibodies (UI/mL) | Basal and final (after 3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Thyroid stimulating hormone at 3 months | Serum Thyroid stimulating hormone (TSH) (uIU/mL) | Basal and final (after 3 months) | 
| Change from baseline Free thyroxine at 3 months | Serum Free thyroxine (FT4) (ng/dL) | Basal and final (after 3 months) | 
| Change from baseline Total triiodothyronine at 3 months | Serum Total triiodothyronine (T3) (ng/dL) | Basal and final (after 3 months) | 
| Change from baseline Lipid profile at 3 months | Lipid profile: It includes total cholesterol (mg/dl), high-density lipoprotein (HDL) (mg/dl), low-density lipoprotein (LDL) (mg/dl), very low-density lipoprotein (VLDL) (mg/dl), and triglycerides (mg/dl). | Basal and final (after 3 months) | 
| Change from baseline glycemia at 3 months | Fasting glycemia (mg/dl) | Basal and final (after 3 months) | 
| Change from baseline ThyPro-39 at 3 months | Questionnaire ThyPro-39 (Quality of Life Questionnaire for Patients with Thyroid Disease): ThyPRO-39 measures the severity of symptoms and overall health-related quality of life of patients with thyroid disease, self-reported during the previous 4 weeks through a questionnaire. Each item on the questionnaire is rated by a five-point Likert scale (not at all, a little, somewhat, quite a bit, very much/completely). ThyPRO-39 is made up of 39 items in13 scales: goiter symptoms; hyperthyroid symptoms; hypothyroid symptoms; eye symptoms; tiredness; cognitive complaints; anxiety; depressivity; emotional susceptibility; impaired social life; impaired daily life; cosmetic complaints/appearance; and overall quality of life (QoL)-impact scale. | Basal and final (after 3 months) | 
| Change from baseline SF-36 at 3 months | Questionnaire SF-36: The Short Form-36 Health Survey (SF-36) is a generic health-related quality of life (HRQL) questionnaires. The SF-36 Health Questionnaire is composed of 36 questions that assess health status through alternatives in items such as: Physical function, Physical role, Body pain, General health, Vitality, Social function, Emotional role and Mental health. Additionally, it includes an item on the change in general health status compared to the previous year. | Basal and final (after 3 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroid stimulating hormone, Hashimoto Disease, Vitamin D, Antithyroid antibodies