Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
199/MED
Study information
Scientific title
Acronym
Study hypothesis
The cardiovascular risk in people with SCH, health status and quality of life can be improved by treatment with L-thyroxine.
Ethics approval
Not provided at time of registration
Study design
Double blind randomised controlled crossover study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Subclinical hypothyroidism
Intervention
Double blind randomised controlled crossover study using thyroxine (100 mcg/day) versus placebo.
Intervention type
Drug
Phase
Not Specified
Drug names
L-thyroxine
Primary outcome measure
Improvement in brachial artery Flow Mediated Dilatation (FMD) as a marker of vascular endothelial function and Total Cholesterol (TC) levels, after 12 weeks of L-thyroxine treatment.
Secondary outcome measures
Changes in:
1. Health status
2. Quality of life
3. Weight as assessed by body mass index
4. Waist circumference and waist hip ratio
5. Blood pressure
6. Triglyceride
7. High Density Lipoprotein (HDL) cholesterol
8. Low Density Lipoprotein (LDL) cholesterol
9. Apolipoprotein A1 and apolipoprotein B
10. Serum markers of endothelial function (e-selectin, soluble adhesion molecule 1, tissue plasminogen activator and plasminogen activator inhibitor 1) and markers of inflammation high sensitive C-reactive protein
Overall trial start date
01/02/2003
Overall trial end date
10/01/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Subjects from Primary Care (general practices)
2. Aged 18 to 80 years of age
3. Who have at least two abnormal thyroid function tests
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Thyroid disease and its treatment
2. Medications that could cause thyroid hormone dysfunction
3. Diabetes mellitus
4. Renal failure (serum creatinine greater than 120 µmol/l)
5. Vascular disease
6. Psychiatric conditions or its treatment
7. Current or previous pregnancy in the last two years
Recruitment start date
01/02/2003
Recruitment end date
10/01/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen Elizabeth Hospital
Gateshead
NE9 6SX
United Kingdom
Sponsor information
Organisation
Gateshead Health NHS Foundation Trust (UK)
Sponsor details
Queen Elizabeth Hospital
Sheriff Hill
Tyne and Wear
Gateshead
NE9 6SX
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
NHS Research and Development (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Research Endocrine Fund (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Gateshead Diabetes Charitable Fund (UK)
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
Basic results (scientific)
Publication list
For information:
Health status in patients with sub-clinical hypothyroidism. Razvi S, Ingoe LE, McMillan CV, Weaver JU Eur J Endocrinol. 2005;152:713-7.
See http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15879356
For results:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=17299073
Publication citations
-
See
Razvi S, Ingoe LE, McMillan CV, Weaver JU, Health status in patients with sub-clinical hypothyroidism., Eur. J. Endocrinol., 2005, 152, 5, 713-717, doi: 10.1530/eje.1.01907.
-
For results
Razvi S, Ingoe L, Keeka G, Oates C, McMillan C, Weaver JU, The beneficial effect of L-thyroxine on cardiovascular risk factors, endothelial function, and quality of life in subclinical hypothyroidism: randomized, crossover trial., J. Clin. Endocrinol. Metab., 2007, 92, 5, 1715-1723, doi: 10.1210/jc.2006-1869.