Evening versus morning administration of levothyroxine

ISRCTN	ISRCTN17436693
DOI	https://doi.org/10.1186/ISRCTN17436693
Secondary identifying numbers	2006/45

Submission date: 30/05/2007
Registration date: 30/05/2007
Last edited: 03/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A. Berghout
Scientific

Medisch Centrum Rijnmond Zuid
Afdeling Interne Geneeskunde
Rotterdam
-
Netherlands

Phone	+31 (0)10 2911911
Email	berghouta@mcrz.nl

Study information

Study design	Randomised, double blinded, placebo controlled, crossover trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Evening versus morning administration of levothyroxine: a randomised controlled double-blind trial
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Levothyroxine
Primary outcome measure	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 study start date	01/05/2007
Completion date	01/05/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	100
Key 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
Key exclusion criteria	1. Pregnancy 2. Disease of the stomach, jejunum or ileum 3. Use of medication known to interfere with the uptake of levothyroxine
Date of first enrolment	01/05/2007
Date of final enrolment	01/05/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Medisch Centrum Rijnmond Zuid

Rotterdam
-
Netherlands

Sponsor information

Medical Centre Rijnmond-Zuid (MCRZ) (The Netherlands)
Hospital/treatment centre

Groene Hilledijk 315
Rotterdam
3075
Netherlands

"ROR"	https://ror.org/01n0rnc91

Funders

Funder type

Not defined

Van Puyvelde Fonds (from private funds)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	pilot study results	01/01/2007		Yes	No
Results article	main trial results	13/12/2010		Yes	No

Editorial Notes

03/10/2017: Publication reference added.