Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
03/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr S.A. Eskes

ORCID ID

Contact details

Academic Medical Centre
Department of Endocrinology
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR87; MEC number: 04/072

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised double blind, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Euthyroidism

Intervention

Selenium supplementation or placebo

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Change of TPO-antibody concentration,
2. Difference in TSH level

Secondary outcome measures

1. Development of subclinical or overt hypothyroidism
2. Quality of life estimation

Overall trial start date

01/08/2005

Overall trial end date

31/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Thyroid peroxidase antibodies greater than 100 kU/l
2. Thyroid stimulating hormone (TSH) 0.4 - 4.0 mE/L
3. Free thyroxine (FT4) 10 - 23 pmol/l
4. Triiodothyronine (T3) 1.30 - 2.70 nmol/L
5. Female sex

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

150

Participant exclusion criteria

1. Use of multivitamin tablets containing selenium in the month preceding inclusion
2. Drug or alcohol abuse
3. No informed consent

Recruitment start date

01/08/2005

Recruitment end date

31/07/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Department of Internal Medicine
Meibergdreef 9
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (AMC) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes