Vitamin DNCT06726967
Vitamin D, Hashimato's Thyroiditis and Thyroid Functions
An observational study of Vitamin D and Thyroid Autoimmune Disease, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this retrospective observational study is to determine whether vitamin D levels differ in patients with Hashimoto's thyroiditis (HT) compared to those without Hashimoto's thyroiditis. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D, Thyroid Autoimmune Disease
- What is being tested?
- vitamin D 25(OH)D
- How many people
- 81,180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 1 Jan 2024
- Phase
- Observational
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who apply to the Endocrinology Clinic of Ankara Bilkent City Hospital
Who may be able to join
- Patients with the following biochemical parameters:
- Vitamin D (25(OH)D) levels
- Thyroid-stimulating hormone (TSH) levels
- Free triiodothyronine (fT3) levels
- Free thyroxine (fT4) levels
- Anti-thyroid peroxidase (anti-TPO) levels
- Anti-thyroglobulin (anti-Tg) levels
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Çankaya, 06800
About this study
Official title: The Relationship Between Vitamin D Levels, Thyroid Functions, and Thyroid Autoimmunity
The goal of this retrospective observational study is to determine whether vitamin D levels differ in patients with Hashimoto's thyroiditis (HT) compared to those without Hashimoto's thyroiditis. The main research questions are:
Are vitamin D levels lower in HT patients compared to non-HT patients? Do vitamin D levels vary between HT and non-HT patients based on thyroid function status?
The study was conducted by retrospectively reviewing the medical records of patients who visited the hospital outpatient clinic.
- Conditions
- Vitamin D, Thyroid Autoimmune Disease
- Being tested
- vitamin D 25(OH)D
- Keywords
- vitamin D, Thyroid autoimmunity, hashimato's thyroiditis, thyroid functions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D 25(OH)DDiagnostic test
Also called Thyroid functions, Thyroid antibodies
Thyroid functions (thyroid-stimulating hormone (TSH), serbest triiodothyronine (fT3), serbest thyroxine (fT4)); Thyroid antibodies (Anti-thyroid peroxidase (anti-TPO), anti-thyroglobulin (anti-TG))
| Study group | Role | What they receive |
|---|---|---|
| Adults | Patients with thyroid function tests (thyroid-stimulating hormone (TSH), free T3 (fT3), free T4 (fT4)), thyroid antibodies (anti-Tg, anti-TPO), and 25(OH) vitamin D levels Receives: Diagnostic Test: vitamin D 25(OH)D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D 25 OH D
nmol/L
Measured: Baseline
thyroid-stimulating hormone (TSH)
uIU/mL
Measured: Baseline
free thyroxine (fT4)
ng/dL
Measured: Baseline
Anti-thyroid peroxidase (anti-TPO)
IU/mL
Measured: Baseline
anti-thyroglobulin (anti-TG)
IU/mL
Measured: Baseline
Secondary outcomes (1)
free triiodothyronine (fT3)
pg/ml
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Feb 2019
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin DStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 81,180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Responsible party
- Principal investigator, Rahime Evra KARAKAYA, Ankara Yildirim Beyazıt University
- Investigators
- Rahime E Karakaya, PhD, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726967
- Sponsor's protocol ID
- AnkaraYBU-KARAKAYA005
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Vitamin D Levels, Thyroid Functions, and Thyroid Autoimmunity
- ClinicalTrials.gov ID
- NCT06726967
- Acronym / sponsor ID
- AnkaraYBU-KARAKAYA005
- Conditions
- Vitamin D, Thyroid Autoimmune Disease
- Keywords
- vitamin D, Thyroid autoimmunity, hashimato's thyroiditis, thyroid functions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81,180 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 10 Dec 2024 (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 goal of this retrospective observational study is to determine whether vitamin D levels differ in patients with Hashimoto's thyroiditis (HT) compared to those without Hashimoto's thyroiditis. The main research questions are:
Are vitamin D levels lower in HT patients compared to non-HT patients? Do vitamin D levels vary between HT and non-HT patients based on thyroid function status?
The study was conducted by retrospectively reviewing the medical records of patients who visited the hospital outpatient clinic.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults | – | Diagnostic Test: vitamin D 25(OH)DPatients with thyroid function tests (thyroid-stimulating hormone (TSH), free T3 (fT3), free T4 (fT4)), thyroid antibodies (anti-Tg, anti-TPO), and 25(OH) vitamin D levels |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who apply to the Endocrinology Clinic of Ankara Bilkent City Hospital
Key inclusion criteria (7 listed)
- Vitamin D (25(OH)D) levels
- Thyroid-stimulating hormone (TSH) levels
- Free triiodothyronine (fT3) levels
- Free thyroxine (fT4) levels
- Anti-thyroid peroxidase (anti-TPO) levels
Key exclusion criteria (1 listed)
- -
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 25(OH)DAlso: Thyroid functions, Thyroid antibodiesThyroid functions (thyroid-stimulating hormone (TSH), serbest triiodothyronine (fT3), serbest thyroxine (fT4)); Thyroid antibodies (Anti-thyroid peroxidase (anti-TPO), anti-thyroglobulin (anti-TG)) | Diagnostic test | Adults |
Primary outcome
Vitamin D 25 OH D
Time frame: Baseline
nmol/L
thyroid-stimulating hormone (TSH)
Time frame: Baseline
uIU/mL
free thyroxine (fT4)
Time frame: Baseline
ng/dL
Anti-thyroid peroxidase (anti-TPO)
Time frame: Baseline
IU/mL
anti-thyroglobulin (anti-TG)
Time frame: Baseline
IU/mL
1 secondary outcome
free triiodothyronine (fT3)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
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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.
Rahime E Karakaya, PhD principal investigator
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D and Thyroid Autoimmune Disease, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 10 Dec 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D 25 OH D (time frame: Baseline). The study lists 5 primary outcomes in all. 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 10 Dec 2024.