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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR959 |
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Date of registration:
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17/04/2007 |
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Primary sponsor: |
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Public title:
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Evening versus Morning Administration of Levothyroxine: a randomised controlled double-blind trial
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Scientific title:
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Evening versus Morning Administration of Levothyroxine: a randomised controlled double-blind trial -
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Date of first enrolment:
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1/5/2007 |
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Target sample size:
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100 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=959 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Not applicable; Group: Crossover; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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N.
Bolk |
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Address:
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Erasmus Medisch Centrum,
Afdeling Endocrinologie
Rotterdam
The Netherlands |
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Telephone:
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+31 10-4639222 |
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Email:
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nienkebolk@hotmail.com |
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Affiliation:
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Name:
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A.
Berghout |
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Address:
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Medisch Centrum Rijnmond Zuid,
Afdeling Interne Geneeskunde
Rotterdam
The Netherlands |
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Telephone:
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+31 10-2911911 |
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Email:
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berghouta@mcrz.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients with primary hypothyroidism;
2. Above the age of 18 years old;
3. On a stable regimen of levothyroxine for at least 6 months.
Exclusion criteria: 1. Pregnancy;
2. Disease of the stomach;
3. Jejunum or ileum;
4. Use of medication known to interfere with the uptake of levothyroxine
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Quality of life, Atopic eczema, Levothyroxine
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Intervention(s)
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During the study, patients will have to take 2 tablets a day (one in the morning and one at bedtime), instead of 1 tablet. One of the tablets is levothyroxine, the other placebo. After 3 months the tablets will be switched. During these 24 weeks the patients will return to the outpatient department five times for a check-up, and bloodsamples will be taken
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Primary Outcome(s)
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Significant change in TSH and thyroid hormones FT4/T3
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Secondary Outcome(s)
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1 Change in:
a. blood pressure;
b. pulse;
c. weight;
d. other lab results (creatinine, lipids);
2. Change in quality of life;
3. Symptoms of hypo-or hyperthyroidism.
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Secondary ID(s)
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2006/45
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ISRCTN17436693
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Source(s) of Monetary Support
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Van Puyvelde Fonds (private fund)
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