Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT02384668
Eligibility Criteria:
Inclusion Criteria:
* A first time diagnosis of Graves' hyperthyroidism within the last three months, confirmed by TSH below 0.01 IU/L, and T3 or T4 levels above the reference interval necessitating ATD therapy
* Positive TRAb
* Speak and read Danish
* Written informed consent
Exclusion Criteria:
* Previously diagnosed hyperthyroidism
* ATD treatment initiated more than 3 months prior to inclusion
* Planned ablative therapy (radioactive iodine or thyroid surgery)
* Intake of more than 10 µg D-vitamin/day that the participant wishes to continue.
* Chronic granulomatous illness
* Persistent hypercalcemia (plasma calcium \> 1.40 mmol/L)
* Reduced kidney function (eGFR \< 45 ml/min)
* Treatment with immunomodulatory drugs
* Active malignant disease
* Alcohol or drug abuse
* Pregnancy at inclusion
* Major comorbidity, making the participant unlikely to continuously receive trial intervention.
* Allergy towards the components in the D-vitamin or the placebo pills.
* Unable to read and understand Danish
* Lack of informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02384668
Study Brief:
Protocol Section:
NCT02384668