D-vitamin And Graves' Disease; Morbidity And Relapse Reduction (NCT02384668) | Clinical Trial Compass
CompletedNot Applicable
D-vitamin And Graves' Disease; Morbidity And Relapse Reduction
Denmark278 participantsStarted 2015-03-24
Plain-language summary
The purpose of this study is to investigate the effects of vitamin D supplementation on morbidity and risk of relapse in patients with Graves' disease.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Proportion of participants without relapse within the first year after cessation of ATD treatment.
Timeframe: 0-12 months after cessation of ATD treatment