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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04778865
Other study ID # 004/2020
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 20, 2020
Est. completion date December 2021

Study information

Verified date February 2021
Source Universidad de Valparaiso
Contact Isabella A Vicuña, Master
Phone 56-976614192
Email isabella.vicuna@uv.cl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Intervention

Dietary Supplement:
Vitamin D-correction
Capsule with 50.000 UI cholecalciferol
Vitamin D-RDA
Capsule with 4.2000 UI cholecalciferol

Locations

Country Name City State
Chile Escuela de Nutrición. Facultad de Farmacia. Universidad de Valparaíso. Valparaíso

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Valparaiso

Country where clinical trial is conducted

Chile, 

Outcome

Type Measure Description Time frame Safety issue
Other Change from baseline 25(OH)D at 3 months 25(OH)D (ng/mL) Basal and final (after 3 months)
Other Change from baseline Parathormone at 3 months Parathormone (pg/mL) Basal and final (after 3 months)
Other Change from baseline calcium at 3 months serum calcium (mg/dL) Basal and final (after 3 months)
Other Change from baseline phosphorus at 3 months phosphorus (mg/dL) Basal and final (after 3 months)
Primary Change from baseline antithyroid antibodies at 3 months Anti-thyroid peroxidase and anti-thyroglobulin antibodies (UI/mL) Basal and final (after 3 months)
Secondary Change from baseline Thyroid stimulating hormone at 3 months Serum Thyroid stimulating hormone (TSH) (uIU/mL) Basal and final (after 3 months)
Secondary Change from baseline Free thyroxine at 3 months Serum Free thyroxine (FT4) (ng/dL) Basal and final (after 3 months)
Secondary Change from baseline Total triiodothyronine at 3 months Serum Total triiodothyronine (T3) (ng/dL) Basal and final (after 3 months)
Secondary 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)
Secondary Change from baseline glycemia at 3 months Fasting glycemia (mg/dl) Basal and final (after 3 months)
Secondary 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)
Secondary 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)
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