Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/05/2007
Date assigned
30/05/2007
Last edited
30/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Medical Centre Rijnmond-Zuid (MCRZ) (The Netherlands)

Sponsor details

Groene Hilledijk 315
Rotterdam
3075
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

  1. 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.

Additional files

Editorial Notes