Subclinical hypothyroidism (SCH), cardiovascular risk and quality of life
| ISRCTN | ISRCTN35570362 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35570362 |
| Secondary identifying numbers | 199/MED |
- Submission date
- 19/09/2005
- Registration date
- 19/10/2005
- Last edited
- 09/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jolanta Weaver
Scientific
Scientific
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
Study information
| Study design | Double blind randomised controlled crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/02/2003 |
| Completion date | 10/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Queen Elizabeth Hospital
Gateshead
NE9 6SX
United Kingdom
NE9 6SX
United Kingdom
Sponsor information
Gateshead Health NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Queen Elizabeth Hospital
Sheriff Hill
Tyne and Wear
Gateshead
NE9 6SX
England
United Kingdom
| Website | http://www.gatesheadhealth.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/01aye5y64 |
Funders
Funder type
Charity
NHS Research and Development (UK)
No information available
Research Endocrine Fund (UK)
No information available
Gateshead Diabetes Charitable Fund (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | See | 01/05/2005 | Yes | No | |
| Results article | 01/05/2007 | Yes | No |
Editorial Notes
09/11/2022: Total final enrolment added.
