Status:
UNKNOWN
Effect of Treatment for Vitamin D Deficiency on Thyroid Function and Autoimmunity in Hashimoto's Thyroiditis.
Lead Sponsor:
Universidad de Valparaiso
Conditions:
Hashimoto Disease
Treatment Levothyroxine
Eligibility:
All Genders
18-60 years
Phase:
NA
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 axi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04778865
Start Date
November 20 2020
End Date
December 1 2021
Last Update
March 3 2021
Active Locations (1)
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1
Escuela de Nutrición. Facultad de Farmacia. Universidad de Valparaíso.
Valparaíso, Chile