D-vitamin And Graves' Disease; Morbidity And Relapse Reduction

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.

Conditions

• Graves' Disease

Interventions

DIETARY_SUPPLEMENT

Cholecalciferol

One tablet per day. The duration of the intervention period is between 24-36 months. This is defined by the time of ATD treatment withdrawal, which is scheduled between approximately 12-18(-24) months after randomisation. Vitamin D supplementation will continue 12 months after withdrawal of ATD treatment or until relapse of Graves' Disease if this occurs prior.

DIETARY_SUPPLEMENT

Placebo

One tablet per day. Placebo tablet identical in appearance to cholecalciferol tablet. Duration and cessation of treatment identical to intervention with cholecalciferol.

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• Regionshospitalet Silkeborg

  collaborator OTHER

• Regional Hospital Holstebro

  collaborator OTHER

• Regionshospitalet Horsens

  collaborator OTHER

• Randers Regional Hospital

  collaborator OTHER

• Regionshospitalet Viborg, Skive

  collaborator OTHER

• Herning Hospital

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Lars Rejnmark, Professor · Aarhus University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-24

Primary Completion

2020-12-31

Completion

2020-12-31

Countries

• Denmark

Study Locations