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

NCT04778865 | Unknown DMC

• 1 other identifier: 004/2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hashimoto Disease; Treatment Levothyroxine; Vitamin D Deficiency

Keywords

Hashimoto Disease; Vitamin D; Antithyroid antibodies; Thyroid stimulating hormone

Outcome Measures

Primary Outcomes (1)

• Change from baseline antithyroid antibodies at 3 months

  Anti-thyroid peroxidase and anti-thyroglobulin antibodies (UI/mL)

  Basal and final (after 3 months)

Secondary Outcomes (7)

• Change from baseline Thyroid stimulating hormone at 3 months

  Basal and final (after 3 months)

• Change from baseline Free thyroxine at 3 months

  Basal and final (after 3 months)

• Change from baseline Total triiodothyronine at 3 months

  Basal and final (after 3 months)

• Change from baseline Lipid profile at 3 months

  Basal and final (after 3 months)

• Change from baseline glycemia at 3 months

  Basal and final (after 3 months)

Other Outcomes (4)

• Change from baseline 25(OH)D at 3 months

  Basal and final (after 3 months)

• Change from baseline Parathormone at 3 months

  Basal and final (after 3 months)

• Change from baseline calcium at 3 months

  Basal and final (after 3 months)

Study Arms (2)

Vitamin D-correction

EXPERIMENTAL

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

Dietary Supplement: Vitamin D-correction

Vitamin D-RDA

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin D-RDA

Interventions

Vitamin D-correction DIETARY_SUPPLEMENT

Capsule with 50.000 UI cholecalciferol

Vitamin D-correction

Vitamin D-RDA DIETARY_SUPPLEMENT

Capsule with 4.2000 UI cholecalciferol

Vitamin D-RDA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Valparaiso: lead

Study Sites (1)

Escuela de Nutrición. Facultad de Farmacia. Universidad de Valparaíso.

Valparaíso, Chile

RECRUITING

MeSH Terms

Conditions

Hashimoto Disease; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Thyroiditis, Autoimmune; Thyroiditis; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Isabella A Vicuña, Master

CONTACT

56-976614192; isabella.vicuna@uv.cl

Claudia A Vega, Master

CONTACT

5632-2508440; claudia.vega@uv.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nutritionist

Model Details: 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.

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 3, 2021
• Study Start: November 20, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 3, 2021

Record last verified: 2021-02

Locations

CL (1)