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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04778865
• Other study ID #: 004/2020
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Hashimoto Disease
• Thyroiditis
• Treatment Levothyroxine
• Vitamin D Deficiency

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)