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

Not Applicable

• Conditions: Hashimoto Disease; Treatment Levothyroxine; Vitamin D Deficiency
• Interventions: Dietary Supplement: Vitamin D-correction; Dietary Supplement: Vitamin D-RDA

• Registration Number: NCT04778865
• Lead Sponsor: Universidad de Valparaiso

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-20
• Status Verified: 2021-02
• Study First Submitted: 2021-02-24
• Study First Submitted QC: 2021-02-26
• Last Update Submitted: 2021-02-26
• Study First Posted: 2021-03-03
• Last Update Posted: 2021-03-03
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vitamin D-correction	Vitamin D-correction	Subjects will receive one capsule with 50.000 IU cholecalciferol weekly for 3 months.
Vitamin D-RDA	Vitamin D-RDA	Subjects will receive one capsule with 4.200 IU cholecalciferol weekly for 3 months.

Primary Outcome Measures

Name	Time	Method
Change from baseline antithyroid antibodies at 3 months	Basal and final (after 3 months)	Anti-thyroid peroxidase and anti-thyroglobulin antibodies (UI/mL)

Secondary Outcome Measures

Name	Time	Method
Change from baseline Thyroid stimulating hormone at 3 months	Basal and final (after 3 months)	Serum Thyroid stimulating hormone (TSH) (uIU/mL)
Change from baseline Free thyroxine at 3 months	Basal and final (after 3 months)	Serum Free thyroxine (FT4) (ng/dL)
Change from baseline Total triiodothyronine at 3 months	Basal and final (after 3 months)	Serum Total triiodothyronine (T3) (ng/dL)
Change from baseline Lipid profile at 3 months	Basal and final (after 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).
Change from baseline glycemia at 3 months	Basal and final (after 3 months)	Fasting glycemia (mg/dl)
Change from baseline ThyPro-39 at 3 months	Basal and final (after 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.
Change from baseline SF-36 at 3 months	Basal and final (after 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.

Trial Locations

Locations (1)

Escuela de Nutrición. Facultad de Farmacia. Universidad de Valparaíso.; 🇨🇱 Valparaíso, Chile