No registrations found.
ID
NL-OMON22027
Source
NTR
Brief title
N/A
Intervention
Outcome measures
Primary outcome
Change of TPO-antibody concentration, difference in TSH level.
Secondary outcome
Development of subclinical or overt hypothyroidism and quality of life estimation.
Background summary
N/A
Study objective
N/A
Study design
N/A
Intervention
Selenium supplementation or placebo.
Public
Academic Medical Center (AMC),
Department of Endocrinology,
P.O. Box 22660
S.A. Eskes
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
S.A.Eskes@amc.uva.nl
Department of Endocrinology,
P.O. Box 22660
S.A. Eskes
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
S.A.Eskes@amc.uva.nl
Scientific
Academic Medical Center (AMC),
Department of Endocrinology,
P.O. Box 22660
S.A. Eskes
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
S.A.Eskes@amc.uva.nl
Department of Endocrinology,
P.O. Box 22660
S.A. Eskes
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
S.A.Eskes@amc.uva.nl
Inclusion criteria
Thyroid 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 criteria
Use of multivitamin tablets containing selenium in the month preceding inclusion, drug or alcohol abuse, no informed consent.
Design
Study type
:
Interventional
Intervention model
:
Parallel
Allocation
:
Randomized controlled trial
Masking
:
Double blinded (masking used)
Control
:
Placebo
Recruitment
NL
Recruitment status
:
Recruitment stopped
Start date (anticipated)
:
Enrollment
:
150
Type
:
Actual
Positive opinion
Date
:
Application type
:
First submission
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL58 |
| NTR-old | NTR87 |
| Other | MEC : 04/072 |
| ISRCTN | ISRCTN26633557 |
Summary results
N/A