Combined treatment with thyroxine plus triiodothyronine for primary hypothyroidism in humans
| ISRCTN | ISRCTN85948357 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85948357 |
| Protocol serial number | PI27/99 |
| Sponsor | Hospital Ramón y Cajal, Madrid (Spain) |
| Funder | 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. |
- 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
Scientific
Department of Endocrinology
Hospital Ramón y Cajal
Carretera de Colmenar km 9,1
Madrid
28034
Spain
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Hypothyroidism |
| Intervention | A 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 type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Levothyroxine, liothyronine |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Key inclusion criteria | Inclusion 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 criteria | Exclusion 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 enrolment | 01/04/2000 |
| Date of final enrolment | 31/05/2005 |
Locations
Countries of recruitment
- Spain
Study participating centre
Department of Endocrinology
Madrid
28034
Spain
28034
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
