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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vitamin D Deficiency; Hashimoto Disease; Treatment Levothyroxine
• Intervention / Treatment: Dietary supplement: Vitamin D-correction; Dietary supplement: Vitamin D-RDA

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabella A Vicuña, Master; Phone Number: 56-976614192; Email: isabella.vicuna@uv.cl
• Study Contact Backup: Name: Claudia A Vega, Master; Phone Number: 5632-2508440; Email: claudia.vega@uv.cl

Study Locations

• Chile
  • Valparaíso, Chile
    • Recruiting
    • Escuela de Nutrición. Facultad de Farmacia. Universidad de Valparaíso.
    • Contact: Isabella A Vicuña, Master; Phone Number: 56-976614192; Email: isabella.vicuna@uv.cl
    • Contact: Claudia A Vega, Master; Phone Number: 5632-2508440; Email: claudia.vega@uv.cl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Thyroid stimulating hormone at 3 months	Serum Thyroid stimulating hormone (TSH) (uIU/mL)	Basal and final (after 3 months)
Change from baseline Free thyroxine at 3 months	Serum Free thyroxine (FT4) (ng/dL)	Basal and final (after 3 months)
Change from baseline Total triiodothyronine at 3 months	Serum Total triiodothyronine (T3) (ng/dL)	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).	Basal and final (after 3 months)
Change from baseline glycemia at 3 months	Fasting glycemia (mg/dl)	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.	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.	Basal and final (after 3 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline 25(OH)D at 3 months	25(OH)D (ng/mL)	Basal and final (after 3 months)
Change from baseline Parathormone at 3 months	Parathormone (pg/mL)	Basal and final (after 3 months)
Change from baseline calcium at 3 months	serum calcium (mg/dL)	Basal and final (after 3 months)
Change from baseline phosphorus at 3 months	phosphorus (mg/dL)	Basal and final (after 3 months)

Collaborators and Investigators

• Sponsor: Universidad de Valparaiso

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: February 26, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Vitamin D; Hashimoto Disease; Antithyroid antibodies; Thyroid stimulating hormone
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Thyroid Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Thyroiditis, Autoimmune; Vitamin D Deficiency; Hashimoto Disease; Thyroiditis; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: 004/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No