CHATS: Central Hypothyroidism And Adjusted Thyroxine Dose Study (Chats): Impact Of Increasing Free Thyroxine Levels In Patients With Hypopituitarism
ISRCTN | ISRCTN69841377 |
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DOI | https://doi.org/10.1186/ISRCTN69841377 |
Secondary identifying numbers | N0063173623 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 17/01/2012
- 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
Prof S M Shalet
Scientific
Scientific
Endocrinology
Christie Hospital NHS Trust
Wilsmlow Road
Withington
Manchester
M20 4BX
United Kingdom
Phone | +44 0161 446 3667 |
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stephen.m.shalet@man.ac.uk |
Study information
Study design | Randomised, double-blind, placebo-controlled study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Quality of life |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | |
Study objectives | Primary objective of the study: impact of increased thyroxine supplementation on quality of life. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Nutritional, Metabolic, Endocrine: Hypopituitarism |
Intervention | Arm A: Thryoxine Arm B: Placebo |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Thryoxine |
Primary outcome measure | QoL assessment with: 1. PGWB (Psychological General Well-Being Schedule) 2. SF-36 (Medical Outcomes Study Short Form36) 3. EQ-5D (EuroQol EQ-5D) and questionnaires |
Secondary outcome measures | 1.Thyroid-specific symptom questionnaire 2. QoL assessment with QoL-AGHDA 3. BP, HR 4. fT4, fT3, TSH 5. CK, SHBG 6. Fasting TC, LDL-C, HDL-C, Lp(a) 7. Body composition, BMI 8. ECG and 24 hour Holter ECG 9. Carotid intima-media thickness measurement |
Overall study start date | 23/09/2005 |
Completion date | 31/12/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Not Specified |
Target number of participants | A total of 80 patients are required for the trial. |
Key inclusion criteria | Patients (aged 20-70) with hypopituitarism and low-normal free thyroxine levels. |
Key exclusion criteria | 1. Age <20 or >70 years 2. Inability to give informed consent 3. Obvious or suspected poor compliance 4. Thyrotoxicosis 5. Severe concomitant illness with significant impact on life expectancy 6. Active acromegaly or Cushing's disease 7. Uncontrolled cardiac arrhythmias or unstable ischaemic heart disease 8. Treatment with Amiodarone or Lithium within the last 6 months 9. Current treatment with: L-Tri-iodothyronine, Carbimazole, Propylthiouracil |
Date of first enrolment | 23/09/2005 |
Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Endocrinology
Manchester
M20 4BX
United Kingdom
M20 4BX
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Christie Hospital NHS Trust
No information available
NHS R&D Support Funding
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/01/2007 | Yes | No |