Selenium Supplementation in Autoimmune Thyroiditis

Summary

Our aim is to investigate if selenium supplementation versus placebo adjuvant to the standard treatment with levothyroxine (LT4) in patients with autoimmune thyroiditis will lead to improved thyroid specific quality of life, and reduced autoimmune activity. The trial will include 472 participants (2 X 236) from four clinical trial sites.

Conditions

• Autoimmune Thyroiditis

Interventions

DIETARY_SUPPLEMENT

SelenoPRECISE

Produced by Pharma Nord ApS, Vejle, Denmark

DIETARY_SUPPLEMENT

Placebo

Produced by Pharma Nord ApS, Vejle, Denmark

Sponsors & Collaborators

• Rigshospitalet, Denmark

  collaborator OTHER

• Bispebjerg Hospital

  collaborator OTHER

• Esbjerg Hospital - University Hospital of Southern Denmark

  collaborator OTHER

• Pharma Nord

  collaborator INDUSTRY

• The Danish Medical Research Council

  collaborator OTHER

• Region of Southern Denmark

  collaborator OTHER

• University of Southern Denmark

  collaborator OTHER

• Steen Bonnema

  lead OTHER

Principal Investigators

• Steen J Bonnema, MD, DMSc · Odense University Hospital

• Laszlo Hegedüs, MD, DMSc · Odense University Hospital

• Kristian H Winther, MD · Odense University Hospital

• Torquil Watt, MD, PhD · Rigshospitalet, Denmark

• Per Cramon, MD · Rigshospitalet, Denmark

• Ulla Feldt-Rasmussen, MD, DMSc · Rigshospitalet, Denmark

• Åse K Rasmussen, MD, DMSc · Rigshospitalet, Denmark

• Jeppe Gram, MD, PhD · Esbjerg Hospital - University Hospital of Southern Denmark

• Nils J Knudsen, MD, DMSc · Bispebjerg Hospital, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-06-30

Primary Completion

2023-03-23

Completion

2023-03-23

Countries

• Denmark

Study Locations