Plain English Summary
Background and study aims
The thyroid gland is a small gland found in the neck that produces two hormones, thyroxine and triiodothyronine, to help regulate the body’s metabolism. Hypothyroidism is a medical condition where the thyroid gland doesn’t produce enough of these hormones, causing many of the body functions to slow down. Symptoms of the condition include feeling tired and cold, gaining weight, difficulty concentrating and feeling depressed. It is also linked to an increased risk of cardiovascular (for example, heart) disease and oxidative stress. Endothelial Progenitor Cells (EPC) are cells that help regenerate the inner lining (endothelial layer) of blood vessels. They represent a well know marker of cardiovascular risk. The lower the EPC count the higher is the cardiovascular risk. Recent studies have demonstrated that EPC count is reduced in patients suffering from subclinical (without symptoms) hypothyroidism, and that replacement hormone treatment with Levothyroxine is able to restore an EPC count at similar levels to normal. It can therefore be speculated that low EPC count may contribute to the increased cardiovascular risk seen in people with hypothyroidism. One of the aim of this study is to evaluate EPC count either in subclinical hypothyroidism, or in overt (with symptoms) hypothyroidism and see whether there is a link between hypothyroidism and low EPC count. Blood pressure, and blood glucose and lipid levels are also measured to assess patients’ metabolic profile. The other aim of the study is to test the hypothesis that treatment with Levothyroxine is able to restore a normal EPC count in people with hypothyroidism. As already mentioned, hypothyroidism is also a condition characterized by increased oxidative stress, and Selenium, a trace element that is involved in thyroid function and thyroid hormones metabolism, has been shown to have anti-oxidant activity. With this in mind, we also test the hypothesis that Selenium, thanks to its anti-oxidant activity, may have a role in hypothyroid EPC count.
Who can participate?
Adults with hypothyroidism.
What does the study involve?
Participants are randomly allocated into one of 4 groups. Those in group 1 are given Levothyroxine once a day. Hose in group 2 are given 83 mg of Selenium once a day. Those in group 3 are given 166 mg of Selenium once a day. Those in group 4 are given 249 mg of Selenium once a day. All participants have thyroid function tests and EPC count tests at the start of the study and 3 months later. Participants in group 1 have an additional thyroid function test 45 days after starting their treatment to adjust the dose of Levothyroxine if required.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
V. Fazzi Hospital (Italy)
When is the study starting and how long is it expected to run for?
May 2015 to July 2015
Who is funding the study?
V. Fazzi Hospital (Italy)
Who is the main contact?
Dr Roberto Negro
robnegro@tiscali.it
Trial website
Contact information
Type
Scientific
Primary contact
Dr Roberto Negro
ORCID ID
http://orcid.org/0000-0001-9282-4530
Contact details
Piazza F. Muratore
Lecce
73100
Italy
+390832661680
robnegro@tiscali.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Levothyroxine and selenium effect on endothelial progenitor cells count in hypothyroid subjects: an interventional single centre trial
Acronym
Study hypothesis
To test the impact of levothyroxine or selenium in endothelial progenitor cells count in hypothyroid patients
Ethics approval
Not provided at time of registration
Study design
Interventional single centre trial
Primary study design
Interventional
Secondary study design
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Endothelial progenitor cells in hypothyroid patients
Intervention
The study has four treatment arms:
1. First arm, hypothyroid patients received Levothyroxine (once a day)
2. Second arm hypothyroid patients received Selenium 83 mg (once a day)
3. Third arm hypothyroid patients received Selenium 166 mg (one a day)
4. Fourth arm hypothyroid patients received Selenium 249 mg (once a day)
Thyroid function test were checked 45 days after initiation treatment to adjust the dose of Levothyroxine. In all the four arms thyroid function test end Endothelial Progenitor Cell count are checked at baseline and three months later.
Intervention type
Drug
Phase
Drug names
1. Levothyroxine
2. Selenium
Primary outcome measures
EPC count in hypothyroid patients before and three months after treatment
Secondary outcome measures
Anthropometric and biochemical measures before and after treatment
Overall trial start date
01/05/2015
Overall trial end date
31/07/2015
Reason abandoned
Eligibility
Participant inclusion criteria
Hypothyroid patients having TSH>4.5mIU/L and <20mIU/L
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
1. Cardiovascular disease
2. Diabetes
3. Hypertension
4. Drugs interfering with EPC count
Recruitment start date
01/05/2015
Recruitment end date
31/07/2015
Locations
Countries of recruitment
Italy
Trial participating centre
V. Fazzi Hospital
Lecce
73100
Italy
Funders
Funder type
Hospital/treatment centre
Funder name
V. Fazzi Hospital (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The aim is to be published in a peer reviewed endocrine journal.
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting
Publication summary