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

Universidad de Valparaiso

Status: Unknown

Conditions: Treatment Levothyroxine; Vitamin D Deficiency; Hashimoto Disease

Treatments: Dietary Supplement: Vitamin D-correction; Dietary Supplement: Vitamin D-RDA

Study type: Interventional

Funder types: Other

Identifiers

NCT04778865

004/2020

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Vitamin D-correction

Experimental group

Description:

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

Treatment:

Dietary Supplement: Vitamin D-correction

Vitamin D-RDA

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Vitamin D-RDA