CHATS: Central Hypothyroidism And Adjusted Thyroxine Dose Study (Chats): Impact Of Increasing Free Thyroxine Levels In Patients With Hypopituitarism

ISRCTN ISRCTN69841377
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

Endocrinology
Christie Hospital NHS Trust
Wilsmlow Road
Withington
Manchester
M20 4BX
United Kingdom

+44 0161 446 3667
stephen.m.shalet@man.ac.uk

Study information

Study designRandomised, double-blind, placebo-controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality 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 objectivesPrimary 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) studiedNutritional, Metabolic, Endocrine: Hypopituitarism
InterventionArm A: Thryoxine
Arm B: Placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Thryoxine
Primary outcome measureQoL assessment with:
1. PGWB (Psychological General Well-Being Schedule)
2. SF-36 (Medical Outcomes Study Short Form–36)
3. EQ-5D (EuroQol EQ-5D) and questionnaires
Secondary outcome measures1.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 date23/09/2005
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participantsA total of 80 patients are required for the trial.
Key inclusion criteriaPatients (aged 20-70) with hypopituitarism and low-normal free thyroxine levels.
Key exclusion criteria1. 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 enrolment23/09/2005
Date of final enrolment31/12/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Endocrinology
Manchester
M20 4BX
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
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
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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2007 Yes No
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