NCT06726967

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81,180

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2024

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

4.9 years

First QC Date

December 5, 2024

Last Update Submit

December 5, 2024

Conditions

Keywords

vitamin DThyroid autoimmunityhashimato's thyroiditisthyroid functions

Outcome Measures

Primary Outcomes (5)

  • Vitamin D 25 OH D

    nmol/L

    Baseline

  • thyroid-stimulating hormone (TSH)

    uIU/mL

    Baseline

  • free thyroxine (fT4)

    ng/dL

    Baseline

  • Anti-thyroid peroxidase (anti-TPO)

    IU/mL

    Baseline

  • anti-thyroglobulin (anti-TG)

    IU/mL

    Baseline

Secondary Outcomes (1)

  • free triiodothyronine (fT3)

    Baseline

Study Arms (1)

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

Diagnostic Test: vitamin D 25(OH)D

Interventions

vitamin D 25(OH)DDIAGNOSTIC_TEST

Thyroid functions (thyroid-stimulating hormone (TSH), serbest triiodothyronine (fT3), serbest thyroxine (fT4)); Thyroid antibodies (Anti-thyroid peroxidase (anti-TPO), anti-thyroglobulin (anti-TG))

Also known as: Thyroid functions, Thyroid antibodies
Adults

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who apply to the Endocrinology Clinic of Ankara Bilkent City Hospital

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

Study Officials

  • Rahime E Karakaya, PhD

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 10, 2024

Study Start

February 1, 2019

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

December 10, 2024

Record last verified: 2024-12

Locations