Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
17/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 Form–36)
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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes