Evening versus morning administration of levothyroxine
| ISRCTN | ISRCTN17436693 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17436693 |
| Protocol serial number | 2006/45 |
| Sponsor | Medical Centre Rijnmond-Zuid (MCRZ) (The Netherlands) |
| Funder | Van Puyvelde Fonds (from private funds) |
- 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
Scientific
Medisch Centrum Rijnmond Zuid
Afdeling Interne Geneeskunde
Rotterdam
-
Netherlands
| Phone | +31 (0)10 2911911 |
|---|---|
| berghouta@mcrz.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double blinded, placebo controlled, crossover trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Levothyroxine |
| Primary outcome measure(s) |
Significant change in TSH and thyroid hormones Free Thyroxine (FT4)/Free Triiodothyronine (FT3). |
| Key secondary outcome measure(s) |
1 Change in: |
| Completion date | 01/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 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
-
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
