Subclinical hypothyroidism (SCH), cardiovascular risk and quality of life

ISRCTN	ISRCTN35570362
DOI	https://doi.org/10.1186/ISRCTN35570362
Protocol serial number	199/MED
Sponsor	Gateshead Health NHS Foundation Trust (UK)
Funders	NHS Research and Development (UK), Research Endocrine Fund (UK), Gateshead Diabetes Charitable Fund (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Jolanta Weaver
Scientific

Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom

Primary study design	Interventional
Study design	Double blind randomised controlled crossover study
Secondary study design	Randomised controlled trial
Scientific title	Subclinical hypothyroidism (SCH), cardiovascular risk and quality of life
Study objectives	The cardiovascular risk in people with SCH, health status and quality of life can be improved by treatment with L-thyroxine.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Subclinical hypothyroidism
Intervention	Double blind randomised controlled crossover study using thyroxine (100 mcg/day) versus placebo.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	L-thyroxine
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	10/01/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Total final enrolment	100
Key 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
Key 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
Date of first enrolment	01/02/2003
Date of final enrolment	10/01/2005

Queen Elizabeth Hospital

Gateshead
NE9 6SX
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/05/2007		Yes	No
Other publications	See	01/05/2005		Yes	No

09/11/2022: Total final enrolment added.