Levothyroxine and selenium effect on endothelial progenitor cells count in hypothyroid subjects

ISRCTN ISRCTN93811021
DOI https://doi.org/10.1186/ISRCTN93811021
Secondary identifying numbers N/A
Submission date
06/08/2015
Registration date
05/09/2015
Last edited
02/09/2020
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

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

Contact information

Dr Roberto Negro
Scientific

Piazza F. Muratore
Lecce
73100
Italy

ORCiD logoORCID ID 0000-0001-9282-4530
Phone +390832661680
Email robnegro@tiscali.it

Study information

Study designInterventional single-centre trial
Primary study designInterventional
Secondary study design
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleLevothyroxine and selenium effect on endothelial progenitor cells count in hypothyroid subjects: an interventional single centre trial
Study objectivesTo test the impact of levothyroxine or selenium in endothelial progenitor cells count in hypothyroid patients
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedEndothelial progenitor cells in hypothyroid patients
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)1. Levothyroxine 2. Selenium
Primary outcome measureEPC count in hypothyroid patients before and three months after treatment
Secondary outcome measuresAnthropometric and biochemical measures before and after treatment
Overall study start date01/05/2015
Completion date31/07/2015

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants100
Total final enrolment100
Key inclusion criteriaHypothyroid patients having TSH>4.5mIU/L and <20mIU/L
Key exclusion criteria1. Cardiovascular disease
2. Diabetes
3. Hypertension
4. Drugs interfering with EPC count
Date of first enrolment01/05/2015
Date of final enrolment31/07/2015

Locations

Countries of recruitment

  • Italy

Study participating centre

V. Fazzi Hospital
Lecce
73100
Italy

Sponsor information

V. Fazzi Hospital
Hospital/treatment centre

Piazza F. Muratore
Lecce
73100
Italy

ROR logo "ROR" https://ror.org/04fvmv716

Funders

Funder type

Hospital/treatment centre

V. Fazzi Hospital (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planThe aim is to be published in a peer reviewed endocrine journal.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2016 02/09/2020 Yes No

Editorial Notes

02/09/2020: Publication reference and total final enrolment number added.