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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
50
Capsule with 50.000 UI cholecalciferol
Capsule with 4.2000 UI cholecalciferol
Escuela de Nutrición. Facultad de Farmacia. Universidad de Valparaíso.
Valparaíso, Chile
RECRUITINGChange from baseline antithyroid antibodies at 3 months
Anti-thyroid peroxidase and anti-thyroglobulin antibodies (UI/mL)
Time frame: Basal and final (after 3 months)
Change from baseline Thyroid stimulating hormone at 3 months
Serum Thyroid stimulating hormone (TSH) (uIU/mL)
Time frame: Basal and final (after 3 months)
Change from baseline Free thyroxine at 3 months
Serum Free thyroxine (FT4) (ng/dL)
Time frame: Basal and final (after 3 months)
Change from baseline Total triiodothyronine at 3 months
Serum Total triiodothyronine (T3) (ng/dL)
Time frame: 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).
Time frame: Basal and final (after 3 months)
Change from baseline glycemia at 3 months
Fasting glycemia (mg/dl)
Time frame: 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.
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Time frame: 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.
Time frame: Basal and final (after 3 months)