Contact information
Type
Scientific
Primary contact
Dr A. Berghout
ORCID ID
Contact details
Medisch Centrum Rijnmond Zuid
Afdeling Interne Geneeskunde
Rotterdam
-
Netherlands
+31 (0)10 2911911
berghouta@mcrz.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2006/45
Study information
Scientific title
Acronym
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.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, double blinded, placebo controlled, crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Hypothyroidism, bedtime levothyroxine, quality of life
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Levothyroxine
Primary outcome measures
Significant change in TSH and thyroid hormones Free Thyroxine (FT4)/Free Triiodothyronine (FT3).
Secondary outcome measures
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
Overall trial start date
01/05/2007
Overall trial end date
01/05/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
1. Pregnancy
2. Disease of the stomach, jejunum or ileum
3. Use of medication known to interfere with the uptake of levothyroxine
Recruitment start date
01/05/2007
Recruitment end date
01/05/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Medisch Centrum Rijnmond Zuid
Rotterdam
-
Netherlands
Funders
Funder type
Not defined
Funder name
Van Puyvelde Fonds (from private funds)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results from pilot study:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17201800
Publication citations
-
Results from pilot study
Bolk N, Visser TJ, Kalsbeek A, van Domburg RT, Berghout A, Effects of evening vs morning thyroxine ingestion on serum thyroid hormone profiles in hypothyroid patients., Clin. Endocrinol. (Oxf), 2007, 66, 1, 43-48, doi: 10.1111/j.1365-2265.2006.02681.x.