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

Sponsor

Universidad de Valparaiso (Other)

Overall Status

Recruiting

CT.gov ID

NCT04778865

Collaborator

(none)

Enrollment

Location

Arms

12.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hashimoto Disease Treatment Levothyroxine Vitamin D Deficiency	Dietary Supplement: Vitamin D-correction Dietary Supplement: Vitamin D-RDA	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Patients will randomly receive the experimental condition or the active comparator for 3 months. After 3 months of washout, the groups will be crossed to receive the opposite treatment.Patients will randomly receive the experimental condition or the active comparator for 3 months. After 3 months of washout, the groups will be crossed to receive the opposite treatment.

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Supportive Care

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.

Actual Study Start Date :

Nov 20, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vitamin D-correction Subjects will receive one capsule with 50.000 IU cholecalciferol weekly for 3 months.	Dietary Supplement: Vitamin D-correction Capsule with 50.000 UI cholecalciferol
Active Comparator: Vitamin D-RDA Subjects will receive one capsule with 4.200 IU cholecalciferol weekly for 3 months.	Dietary Supplement: Vitamin D-RDA Capsule with 4.2000 UI cholecalciferol

Arm

Intervention/Treatment

Experimental: Vitamin D-correction

Subjects will receive one capsule with 50.000 IU cholecalciferol weekly for 3 months.

Dietary Supplement: Vitamin D-correction

Capsule with 50.000 UI cholecalciferol

Active Comparator: Vitamin D-RDA

Subjects will receive one capsule with 4.200 IU cholecalciferol weekly for 3 months.

Dietary Supplement: Vitamin D-RDA

Capsule with 4.2000 UI cholecalciferol

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

Change from baseline 25(OH)D at 3 months [Basal and final (after 3 months)]
25(OH)D (ng/mL)
Change from baseline Parathormone at 3 months [Basal and final (after 3 months)]
Parathormone (pg/mL)
Change from baseline calcium at 3 months [Basal and final (after 3 months)]
serum calcium (mg/dL)
Change from baseline phosphorus at 3 months [Basal and final (after 3 months)]
phosphorus (mg/dL)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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