An interventional study of Vitamin D-correction and Vitamin D-RDA in Hashimoto Disease, Treatment Levothyroxine and Vitamin D Deficiency, sponsored by Universidad de Valparaiso. Status unknown at 1 site in Chile. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-03.
Sponsored by Universidad de Valparaiso · Not applicable, Interventional, and Supportive care
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.
53 studies on the registry are indexed under Hashimoto Disease; 13 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 31 interventional studies indexed under Hashimoto Disease.
Browse Hashimoto Disease studies →Universidad de Valparaiso is the lead sponsor of 29 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive one capsule with 50.000 IU cholecalciferol weekly for 3 months.
Dietary Supplement: Vitamin D-correction
Subjects will receive one capsule with 4.200 IU cholecalciferol weekly for 3 months.
Dietary Supplement: Vitamin D-RDA
Capsule with 50.000 UI cholecalciferol
Capsule with 4.2000 UI cholecalciferol
Change 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.
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)
Change from baseline 25(OH)D at 3 months
25(OH)D (ng/mL)
Time frame: Basal and final (after 3 months)
Change from baseline Parathormone at 3 months
Parathormone (pg/mL)
Time frame: Basal and final (after 3 months)
Change from baseline calcium at 3 months
serum calcium (mg/dL)
Time frame: Basal and final (after 3 months)
Change from baseline phosphorus at 3 months
phosphorus (mg/dL)
Time frame: Basal and final (after 3 months)
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Universidad de Valparaiso