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 range

18 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of participants without relapse within the first year after cessation of ATD treatment.

Timeframe: 0-12 months after cessation of ATD treatment

Trial details

NCT IDNCT02384668

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12

View on ClinicalTrials.gov More Graves' Disease trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.