|
ISRCTN
|
ISRCTN85948357
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Combined treatment with thyroxine plus triiodothyronine for primary hypothyroidism in humans
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
PI27/99
|
|
Study hypothesis
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
Spain
|
|
Disease/condition/study domain
|
Hypothyroidism
|
|
Participants - 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.
|
|
Participants - 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.
|
|
Anticipated start date
|
01/04/2000
|
|
Anticipated end date
|
31/05/2005
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
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
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
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.
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Héctor F
Escobar-Morreale
|
|
Address
|
Department of Endocrinology
Hospital Ramón y Cajal
Carretera de Colmenar km 9,1
|
|
City/town
|
Madrid
|
|
Zip/Postcode
|
28034
|
|
Country
|
Spain
|
|
Sponsor
|
Hospital Ramón y Cajal, Madrid (Spain)
|
|
Address
|
Carretera de Colmenar km 9,1
|
|
City/town
|
Madrid
|
|
Zip/Postcode
|
28034
|
|
Country
|
Spain
|
|
Date applied
|
23/08/2004
|
|
Last edited
|
21/05/2008
|
|
Date ISRCTN assigned
|
28/07/2005
|
