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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D-correction | Experimental | Subjects will receive one capsule with 50.000 IU cholecalciferol weekly for 3 months. |
|
| Vitamin D-RDA | Active Comparator | Subjects will receive one capsule with 4.200 IU cholecalciferol weekly for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D-correction | Dietary Supplement | Capsule with 50.000 UI cholecalciferol |
| |
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline 25(OH)D at 3 months | 25(OH)D (ng/mL) | Basal and final (after 3 months) |
| Change from baseline Parathormone at 3 months | Parathormone (pg/mL) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabella A Vicuña, Master | Contact | 56-976614192 | isabella.vicuna@uv.cl | |
| Claudia A Vega, Master | Contact | 5632-2508440 | claudia.vega@uv.cl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Escuela de NutriciĂłn. Facultad de Farmacia. Universidad de ValparaĂso. | Recruiting | ValparaĂso | Chile |
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| ID | Term |
|---|---|
| D050031 | Hashimoto Disease |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D013967 | Thyroiditis, Autoimmune |
| D013966 | Thyroiditis |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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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.
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| Vitamin D-RDA |
| Dietary Supplement |
Capsule with 4.2000 UI cholecalciferol |
|
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) |
| Basal and final (after 3 months) |
| Change from baseline calcium at 3 months | serum calcium (mg/dL) | Basal and final (after 3 months) |
| Change from baseline phosphorus at 3 months | phosphorus (mg/dL) | Basal and final (after 3 months) |
| D001327 |
| Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |