Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/09/2005
Date assigned
19/10/2005
Last edited
09/05/2007
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

Dr Jolanta Weaver

ORCID ID

Contact details

Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom

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 measures

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

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

http://www.gatesheadhealth.nhs.uk/

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes