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
Protocol serial number	N0063173623
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funders	Christie Hospital NHS Trust, NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof S M Shalet
Scientific

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

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

Primary study design	Interventional
Study design	Randomised, double-blind, placebo-controlled study
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Thryoxine
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2008

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	80
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

Endocrinology

Manchester
M20 4BX
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2007		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes