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Evening versus morning administration of levothyroxine: a randomised controlled double-blind trial
ISRCTN ISRCTN17436693
DOI 10.1186/ISRCTN17436693
ClinicalTrials.gov identifier
EudraCT number
Public title Evening versus morning administration of levothyroxine: a randomised controlled double-blind trial
Scientific title
Acronym N/A
Serial number at source 2006/45
Study hypothesis Administration of levothyroxine at bedtime significantly changes Thyroid Stimulating Hormone (TSH) and thyroid hormone levels compared to morning administration. Quality of life will improve with bedtime administration.
Lay summary
Ethics approval Ethics approval received from the local medical ethics committee
Study design Randomised, double blinded, placebo controlled, crossover trial
Countries of recruitment Netherlands
Disease/condition/study domain Hypothyroidism, bedtime levothyroxine, quality of life
Participants - 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 six months
Participants - exclusion criteria 1. Pregnancy
2. Disease of the stomach, jejunum or ileum
3. Use of medication known to interfere with the uptake of levothyroxine
Anticipated start date 01/05/2007
Anticipated end date 01/05/2008
Status of trial Completed
Patient information material
Target number of participants 100
Interventions During the study, patients will have to take two tablets a day (one in the morning and one at bedtime), instead of one tablet. One of the tablets is levothyroxine, the other placebo. After three 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 blood samples will be taken.
Primary outcome measure(s) Significant change in TSH and thyroid hormones Free Thyroxine (FT4)/Free Triiodothyronine (FT3).
Secondary outcome measure(s) 1 Change in:
1.1. Blood pressure
1.2. Pulse
1.3. Weight
1.4. Other lab results (creatinine, lipids)
2. Change in quality of life
3. Symptoms of hypo-or hyperthyroidism
Sources of funding Van Puyvelde Fonds (from private funds)
Trial website
Publications Results from pilot study:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17201800
Contact name Dr  A.  Berghout
  Address Medisch Centrum Rijnmond Zuid
Afdeling Interne Geneeskunde
  City/town Rotterdam
  Zip/Postcode -
  Country Netherlands
  Tel +31 (0)10 2911911
  Email berghouta@mcrz.nl
Sponsor Medical Centre Rijnmond-Zuid (MCRZ) (The Netherlands)
  Address Groene Hilledijk 315
  City/town Rotterdam
  Zip/Postcode 3075
  Country Netherlands
Date applied 30/05/2007
Last edited 30/05/2007
Date ISRCTN assigned 30/05/2007
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