Combined treatment with thyroxine plus triiodothyronine for primary hypothyroidism in humans

ISRCTN ISRCTN85948357
DOI https://doi.org/10.1186/ISRCTN85948357
Secondary identifying numbers PI27/99
Submission date
23/08/2004
Registration date
28/07/2005
Last edited
21/05/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Héctor F Escobar-Morreale
Scientific

Department of Endocrinology
Hospital Ramón y Cajal
Carretera de Colmenar km 9,1
Madrid
28034
Spain

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedHypothyroidism
InterventionA randomized double-blind crossover design served to compare treatment with 100 µg of levothyroxine per day and treatment with a combination containing 75 µg of levothyroxine plus 5 µg of liothyronine per day, in periods of 8 weeks each. All the patients were also given a combination containing 87.5 µg of levothyroxine plus 7.5 µg of liothyronine per day for a final 8-week period add-on.

The function of the euthyroid healthy external control group was:
1. To evaluate the clinical meaningfulness of any changes detected between treatments in hypothyroid patients, given that subtle differences may be observed, but could not be important if patients were comparable to healthy people when on both treatments
2. To evaluate if patients perform worse than controls irrespective of the treatment applied
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Levothyroxine, liothyronine
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/2000
Completion date31/05/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteriaInclusion criteria required women between 18 and 70 years-old, presenting with overt primary hypothyroidism as defined by increased thyroid-stimulating hormone (TSH) and decreased free T4 serum levels at diagnosis, who maintained serum TSH levels within the normal range on a stable levothyroxine dose of 100 µg per day for at least the previous year.
Key exclusion criteriaExclusion criteria included mental illnesses, affective disorders or use of psychotropic drugs, cardiovascular, renal or hepatic disease, osteoporosis, and treatment with drugs that may interfere with thyroid function other than levothyroxine.

The external euthyroid control group was composed of healthy women.
Date of first enrolment01/04/2000
Date of final enrolment31/05/2005

Locations

Countries of recruitment

  • Spain

Study participating centre

Department of Endocrinology
Madrid
28034
Spain

Sponsor information

Hospital Ramón y Cajal, Madrid (Spain)
Hospital/treatment centre

Carretera de Colmenar km 9,1
Madrid
28034
Spain

ROR logo "ROR" https://ror.org/050eq1942

Funders

Funder type

Industry

Predoctoral fellowships from the Consejería de Educación, Comunidad de Madrid (01/0430/01), and from the Fondo de Investigación Sanitaria (01/F072), Instituto de Salud Carlos III, Ministerio de Sanidad y Consumo, Spain, to one of the Authors. Financial aid came from Merck Darmstad KgaA, Germany.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan