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Selenium supplementation in euthyroid patients with thyroid peroxidase antibodies.


- candidate number0
- NTR NumberNTR87
- ISRCTNISRCTN26633557
- Date ISRCTN created12-sep-2005
- date ISRCTN requested15-aug-2005
- Date Registered NTR6-mei-2005
- Secondary IDs04/072 MEC
- Public TitleSelenium supplementation in euthyroid patients with thyroid peroxidase antibodies.
- Scientific TitleSelenium supplementation in euthyroid patients with thyroid peroxidase antibodies.
- ACRONYMN/A
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedEuthyroidism, Thyroid peroxidase antibodies
- Inclusion criteriaThyroid peroxidase antibodies >100 kU/l, TSH 0.4-4.0 mE/L, FT4 10-23 pmol/l, T3 1.30-2.70 nmol/L, female sex.
- Exclusion criteriaUse of multivitamin tablets containing selenium in the month preceding inclusion, drug or alcohol abuse, no informed consent.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2005
- planned closingdate1-jan-2007
- Target number of participants150
- InterventionsSelenium supplementation or placebo.
- Primary outcomeChange of TPO-antibody concentration, difference in TSH level.
- Secondary outcomeDevelopment of subclinical or overt hypothyroidism and quality of life estimation.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. S.A. Eskes
- CONTACT for SCIENTIFIC QUERIESProf. Dr. W.M. Wiersinga
- Sponsor/Initiator Academic Medical Center (AMC), Department of Internal Medicine
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD15-aug-2005 - 19-okt-2009


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