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van CCT (UK)

van CCT (UK)

Evening versus Morning Administration of Levothyroxine: a randomised controlled double-blind trial

- candidate number2554
- NTR NumberNTR959
- Date ISRCTN created30-mei-2007
- date ISRCTN requested22-mei-2007
- Date Registered NTR17-apr-2007
- Secondary IDs2006/45 
- Public TitleEvening versus Morning Administration of Levothyroxine: a randomised controlled double-blind trial
- Scientific TitleEvening versus Morning Administration of Levothyroxine: a randomised controlled double-blind trial
- hypothesisAdministration of levothyroxine at bedtime significantly changes TSH and thyroid hormone levels compared to morning administration. Quality of life will improve with bedtime administration
- Healt Condition(s) or Problem(s) studiedQuality of life, Atopic eczema, Levothyroxine
- Inclusion criteria1. 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 criteria1. Pregnancy; 2. Disease of the stomach; 3. Jejunum or ileum; 4. Use of medication known to interfere with the uptake of levothyroxine
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupCrossover
- Type-
- Studytypeintervention
- planned startdate 1-mei-2007
- planned closingdate1-mei-2008
- Target number of participants100
- InterventionsDuring 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
- Primary outcomeSignificant change in TSH and thyroid hormones FT4/T3
- Secondary outcome1 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.
- Timepoints
- Trial web site
- statusplanned
- Sponsor/Initiator Medisch Centrum Rijnmond-Zuid
- Funding
(Source(s) of Monetary or Material Support)
Van Puyvelde Fonds (private fund)
- PublicationsClin Endocrinol (Oxf). 2007 Jan;66(1):43-8 Effects of evening vs morning thyroxine ingestion on serum thyroid hormone profiles in hypothyroid patients.Bolk N, Visser TJ, Kalsbeek A, van Domburg RT, Berghout A.
- Brief summaryHypothyroid patients worldwide are advised to take levothyroxine tablets in the morning half an hour before breakfast. This is because a fiber-enriched diet and ingestion of certain drugs have been shown to have an adverse effect on the intestinal absorption of levothyroxine. In a recent study we showed that TSH significantly decreased and T4 and T3 significantly increased after changing the administration time of levothyroxine from morning to the evening, at bedtime. We want to perform a large randomised double blind study among patients with hypothyroidism. In this study patients will be asked to take a capsule in the morning as well as in the evening, with one of these capsules containing levothyroxine and the other capsule being a placebo. The patient and his/her doctor will not know which capsule contains the actual levothyroxine. The hospital pharmacist will perform the randomisation. After 3 months the capsules will be switched, so that the capsule containing levothyroxine is taken at a different moment of the day. Every 6 weeks patients will return to the outpatient department for a check-up and bloodtest. At the start of the study and at 3 and 6 months, patients will fill out quality-of-life forms. Primary endpoint will be a significant change in TSH and FT4/T3 after switching the administration time of levothyroxine to bedtime. Secondary endpoints will be a change in weight, bloodpressure, pulse frequency and change in quality of life.
- Main changes (audit trail)
- RECORD17-apr-2007 - 11-jun-2007

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