Hashimoto DiseaseNCT04778865
Effect of Treatment for Vitamin D Deficiency on Thyroid Function and Autoimmunity in Hashimoto's Thyroiditis.
A study testing Vitamin D-correction and Vitamin D-RDA in people with Hashimoto Disease and Treatment Levothyroxine, run by Universidad de Valparaiso at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hashimoto Disease, Treatment Levothyroxine, Vitamin D Deficiency
- What is being tested?
- Vitamin D-correction and Vitamin D-RDA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChile
- Study dates
- 20 Nov 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Escuela de Nutrición. Facultad de Farmacia. Universidad de Valparaíso.
Valparaíso
Isabella A Vicuña, Master, 56-976614192, isabella.vicuna@uv.cl
Claudia A Vega, Master, 5632-2508440, claudia.vega@uv.cl
About this study
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.
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.
- Being tested
- Vitamin D-correction, Vitamin D-RDA
- Keywords
- Hashimoto Disease, Vitamin D, Antithyroid antibodies, Thyroid stimulating hormone
- Medical subject headings
- Hashimoto Disease, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D-correctionDietary supplement
Capsule with 50.000 UI cholecalciferol
Vitamin D-RDADietary supplement
Capsule with 4.2000 UI cholecalciferol
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D-correction | Experimental | Subjects will receive one capsule with 50.000 IU cholecalciferol weekly for 3 months. Receives: Dietary Supplement: Vitamin D-correction |
| Vitamin D-RDA | Active comparator | Subjects will receive one capsule with 4.200 IU cholecalciferol weekly for 3 months. Receives: Dietary Supplement: Vitamin D-RDA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline antithyroid antibodies at 3 months
Anti-thyroid peroxidase and anti-thyroglobulin antibodies (UI/mL)
Measured: Basal and final (after 3 months)
Secondary outcomes (7)
Change from baseline Thyroid stimulating hormone at 3 months
Serum Thyroid stimulating hormone (TSH) (uIU/mL)
Measured: Basal and final (after 3 months)
Change from baseline Free thyroxine at 3 months
Serum Free thyroxine (FT4) (ng/dL)
Measured: Basal and final (after 3 months)
Change from baseline Total triiodothyronine at 3 months
Serum Total triiodothyronine (T3) (ng/dL)
Measured: Basal and final (after 3 months)
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).
Measured: Basal and final (after 3 months)
Change from baseline glycemia at 3 months
Fasting glycemia (mg/dl)
Measured: Basal and final (after 3 months)
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.
Measured: Basal and final (after 3 months)
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.
Measured: Basal and final (after 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start20 Nov 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hashimoto DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Valparaiso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Vega Soto, Universidad de Valparaiso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778865
- Sponsor's protocol ID
- 004/2020
- Status last verified
- Feb 2021
- First submitted
- 24 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04778865
- Acronym / sponsor ID
- 004/2020
- Keywords
- Hashimoto Disease, Vitamin D, Antithyroid antibodies, Thyroid stimulating hormone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidad de ValparaisoUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vitamin D-correction | Experimental | Dietary Supplement: Vitamin D-correctionSubjects will receive one capsule with 50.000 IU cholecalciferol weekly for 3 months. |
| Vitamin D-RDA | Active comparator | Dietary Supplement: Vitamin D-RDASubjects will receive one capsule with 4.200 IU cholecalciferol weekly for 3 months. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D-correctionCapsule with 50.000 UI cholecalciferol | Dietary supplement | Vitamin D-correction |
| Vitamin D-RDACapsule with 4.2000 UI cholecalciferol | Dietary supplement | Vitamin D-RDA |
Primary outcome
Change from baseline antithyroid antibodies at 3 months
Time frame: Basal and final (after 3 months)
Anti-thyroid peroxidase and anti-thyroglobulin antibodies (UI/mL)
7 secondary outcomes
Change from baseline Thyroid stimulating hormone at 3 months
Time frame: Basal and final (after 3 months)
Change from baseline Free thyroxine at 3 months
Time frame: Basal and final (after 3 months)
Change from baseline Total triiodothyronine at 3 months
Time frame: Basal and final (after 3 months)
Change from baseline Lipid profile at 3 months
Time frame: Basal and final (after 3 months)
Change from baseline glycemia at 3 months
Time frame: Basal and final (after 3 months)
Change from baseline ThyPro-39 at 3 months
Time frame: Basal and final (after 3 months)
Change from baseline SF-36 at 3 months
Time frame: Basal and final (after 3 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D-correction and Vitamin D-RDA in people with Hashimoto Disease and Treatment Levothyroxine, run by Universidad de Valparaiso at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabella A Vicuña, Master (56-976614192, isabella.vicuna@uv.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline antithyroid antibodies at 3 months (time frame: Basal and final (after 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.