Clinical trial NCT04778865: Effect of Treatment for Vitamin D Deficiency on Thyroid Function and Autoimmunity in Hashimoto's Thyroiditis.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hashimoto Disease
Treatment Levothyroxine
Vitamin D Deficiency
Keywords: Hashimoto Disease
Vitamin D
Antithyroid antibodies
Thyroid stimulating hormone
Lead sponsor: Universidad de Valparaiso
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline antithyroid antibodies at 3 months
timeFrame: Basal and final (after 3 months)
Secondary outcomes:
measure: Change from baseline Thyroid stimulating hormone at 3 months
timeFrame: Basal and final (after 3 months)
measure: Change from baseline Free thyroxine at 3 months
timeFrame: Basal and final (after 3 months)
measure: Change from baseline Total triiodothyronine at 3 months
timeFrame: Basal and final (after 3 months)
measure: Change from baseline Lipid profile at 3 months
timeFrame: Basal and final (after 3 months)
measure: Change from baseline glycemia at 3 months
timeFrame: Basal and final (after 3 months)
measure: Change from baseline ThyPro-39 at 3 months
timeFrame: Basal and final (after 3 months)
measure: Change from baseline SF-36 at 3 months
timeFrame: Basal and final (after 3 months)
Other outcomes:
measure: Change from baseline 25(OH)D at 3 months
timeFrame: Basal and final (after 3 months)
measure: Change from baseline Parathormone at 3 months
timeFrame: Basal and final (after 3 months)
measure: Change from baseline calcium at 3 months
timeFrame: Basal and final (after 3 months)
measure: Change from baseline phosphorus at 3 months
timeFrame: Basal and final (after 3 months)
Locations:
city: Valparaíso
country: Chile
facility: Escuela de Nutrición. Facultad de Farmacia. Universidad de Valparaíso.
Study officials:
References: