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

Primary Purpose

Hashimoto Disease, Treatment Levothyroxine, Vitamin D Deficiency

Status
Unknown status
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Vitamin D-correction
Vitamin D-RDA
Sponsored by
Universidad de Valparaiso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hashimoto Disease focused on measuring Hashimoto Disease, Vitamin D, Antithyroid antibodies, Thyroid stimulating hormone

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vitamin D-correction

Vitamin D-RDA

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline antithyroid antibodies at 3 months
Anti-thyroid peroxidase and anti-thyroglobulin antibodies (UI/mL)

Secondary Outcome Measures

Change from baseline Thyroid stimulating hormone at 3 months
Serum Thyroid stimulating hormone (TSH) (uIU/mL)
Change from baseline Free thyroxine at 3 months
Serum Free thyroxine (FT4) (ng/dL)
Change from baseline Total triiodothyronine at 3 months
Serum Total triiodothyronine (T3) (ng/dL)
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).
Change from baseline glycemia at 3 months
Fasting glycemia (mg/dl)
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.
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.

Full Information

First Posted
February 24, 2021
Last Updated
February 26, 2021
Sponsor
Universidad de Valparaiso
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1. Study Identification

Unique Protocol Identification Number
NCT04778865
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Valparaiso

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hashimoto Disease, Treatment Levothyroxine, Vitamin D Deficiency
Keywords
Hashimoto Disease, Vitamin D, Antithyroid antibodies, Thyroid stimulating hormone

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D-correction
Arm Type
Experimental
Arm Description
Subjects will receive one capsule with 50.000 IU cholecalciferol weekly for 3 months.
Arm Title
Vitamin D-RDA
Arm Type
Active Comparator
Arm Description
Subjects will receive one capsule with 4.200 IU cholecalciferol weekly for 3 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D-correction
Intervention Description
Capsule with 50.000 UI cholecalciferol
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D-RDA
Intervention Description
Capsule with 4.2000 UI cholecalciferol
Primary Outcome Measure Information:
Title
Change from baseline antithyroid antibodies at 3 months
Description
Anti-thyroid peroxidase and anti-thyroglobulin antibodies (UI/mL)
Time Frame
Basal and final (after 3 months)
Secondary Outcome Measure Information:
Title
Change from baseline Thyroid stimulating hormone at 3 months
Description
Serum Thyroid stimulating hormone (TSH) (uIU/mL)
Time Frame
Basal and final (after 3 months)
Title
Change from baseline Free thyroxine at 3 months
Description
Serum Free thyroxine (FT4) (ng/dL)
Time Frame
Basal and final (after 3 months)
Title
Change from baseline Total triiodothyronine at 3 months
Description
Serum Total triiodothyronine (T3) (ng/dL)
Time Frame
Basal and final (after 3 months)
Title
Change from baseline Lipid profile at 3 months
Description
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).
Time Frame
Basal and final (after 3 months)
Title
Change from baseline glycemia at 3 months
Description
Fasting glycemia (mg/dl)
Time Frame
Basal and final (after 3 months)
Title
Change from baseline ThyPro-39 at 3 months
Description
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.
Time Frame
Basal and final (after 3 months)
Title
Change from baseline SF-36 at 3 months
Description
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.
Time Frame
Basal and final (after 3 months)
Other Pre-specified Outcome Measures:
Title
Change from baseline 25(OH)D at 3 months
Description
25(OH)D (ng/mL)
Time Frame
Basal and final (after 3 months)
Title
Change from baseline Parathormone at 3 months
Description
Parathormone (pg/mL)
Time Frame
Basal and final (after 3 months)
Title
Change from baseline calcium at 3 months
Description
serum calcium (mg/dL)
Time Frame
Basal and final (after 3 months)
Title
Change from baseline phosphorus at 3 months
Description
phosphorus (mg/dL)
Time Frame
Basal and final (after 3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabella A Vicuña, Master
Phone
56-976614192
Email
isabella.vicuna@uv.cl
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia A Vega, Master
Phone
5632-2508440
Email
claudia.vega@uv.cl
Facility Information:
Facility Name
Escuela de Nutrición. Facultad de Farmacia. Universidad de Valparaíso.
City
Valparaíso
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabella A Vicuña, Master
Phone
56-976614192
Email
isabella.vicuna@uv.cl
First Name & Middle Initial & Last Name & Degree
Claudia A Vega, Master
Phone
5632-2508440
Email
claudia.vega@uv.cl

12. IPD Sharing Statement

Learn more about this trial

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

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