D-vitamin And Graves' Disease; Morbidity And Relapse Reduction
D-vitamin And Graves' Disease; Morbidity And Relapse Reduction
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.
In a multicentre trial, 260 patients with newly diagnosed Graves ' disease will be randomized
 to cholecalciferol 70 mcg/day or placebo in a parallel Group design. Drop outs prior to 31th
 of December 2017 will be replaced. The intervention will continue during treatment with
 antithyroid drugs (ATD), and for a period of 12 months after cessation of ATD. Blood samples
 will be collected at study entry, at 3 and 9 months, and at end of study. QoL questionnaires
 on nine occasions through out the study period. In a subcohort of 80 participants detailed
 examinations of bone density and geometry, muscle strength and postural balance, immune tests
 (N=50), and measurements of arterial stiffness will be performed at study entry, and at 3 and
 9 months after randomisation.
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.