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Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02090907
First Posted: March 18, 2014
Last Update Posted: March 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nasmi Niknam, Isfahan University of Medical Sciences
  Purpose
Hypothyroidism is risk factor in atherosclerotic cardiovascular diseases, but there is a controversy in effect of subclinical hypothyroidism on cardiovascular diseases. We aim to estimate the relation between subclinical hypothyroidism and endothelial dysfunction and the effects of levothyroxine therapy on it. Patients with confirmed subclinical hypothyroidism by lab results will be randomized to two groups of treatment with one daily dose of 100 mg Levothyroxine or placebo. The flow-mediated dilation and intima media thickness are evaluated before and after the study.

Condition Intervention Phase
Subclinical Hypothyroidism Drug: Levothyroxine Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism

Resource links provided by NLM:


Further study details as provided by Nasmi Niknam, Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • Change from baseline flow-mediated dilation at 2 months [ Time Frame: At baseline and then 2 months after treatment ]
    Flow-mediated dilation will be assessed using standard method with a radiologist unaware to the study arms at baseline and then 2 months after treatment.

  • Change from baseline intima-media thickness at 2 months [ Time Frame: At baseline and then 2 months after treatment ]
    Intima-media thickness will be assessed using standard method with a radiologist unaware to the study arms at baseline and then 2 months after treatment.


Enrollment: 50
Study Start Date: May 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levothyroxin
In the treatment group, daily doses of 100 mg of Levothyroxine will be administered every morning, half an hour before breakfast.
Drug: Levothyroxine
Placebo Comparator: Placebo
In the placebo group treatment regimen and advices are identical to that of the treatment group, except for using a pharmacologically neutral agent, with complete resemblance to the real treatment.
Drug: Placebo

  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18 to 65
  • confirmed subclinical hypothyroidism

Exclusion Criteria:

  • receiving of other treatments for hypothyroidism
  • patients with other major medical disorders
  • smoking
  • hyperlipidemia
  • obesity
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090907


Locations
Iran, Islamic Republic of
Khorshid endocrinology clinic
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Principal Investigator: Nasmi Niknam, M.D. Isfahan University of Medical Sciences
  More Information

Publications:
Responsible Party: Nasmi Niknam, Dr., Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02090907     History of Changes
Other Study ID Numbers: 392349
First Submitted: March 12, 2014
First Posted: March 18, 2014
Last Update Posted: March 18, 2014
Last Verified: March 2014

Keywords provided by Nasmi Niknam, Isfahan University of Medical Sciences:
Subclinical hypothyroidism
Atherosclerosis
Cardiovascular disease
Endothelial function
Prevention

Additional relevant MeSH terms:
Hypothyroidism
Thyroid Diseases
Endocrine System Diseases