Contact information
Type
Scientific
Primary contact
Prof S M Shalet
ORCID ID
Contact details
Endocrinology
Christie Hospital NHS Trust
Wilsmlow Road
Withington
Manchester
M20 4BX
United Kingdom
+44 0161 446 3667
stephen.m.shalet@man.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0063173623
Study information
Scientific title
Acronym
Study hypothesis
Primary objective of the study: impact of increased thyroxine supplementation on quality of life.
Ethics approval
Not provided at time of registration
Study design
Randomised, double-blind, placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Nutritional, Metabolic, Endocrine: Hypopituitarism
Intervention
Arm A: Thryoxine
Arm B: Placebo
Intervention type
Drug
Phase
Not Specified
Drug names
Thryoxine
Primary outcome measures
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 trial start date
23/09/2005
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Patients (aged 20-70) with hypopituitarism and low-normal free thyroxine levels.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
A total of 80 patients are required for the trial.
Participant 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
Recruitment start date
23/09/2005
Recruitment end date
31/12/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Endocrinology
Manchester
M20 4BX
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Christie Hospital NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17201804
Publication citations
-
Results
Agha A, Walker D, Perry L, Drake WM, Chew SL, Jenkins PJ, Grossman AB, Monson JP, Unmasking of central hypothyroidism following growth hormone replacement in adult hypopituitary patients., Clin. Endocrinol. (Oxf), 2007, 66, 1, 72-77, doi: 10.1111/j.1365-2265.2006.02688.x.