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Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism

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ClinicalTrials.gov Identifier: NCT02090907
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : March 18, 2014
Sponsor:
Information provided by (Responsible Party):
Nasmi Niknam, Isfahan University of Medical Sciences

Brief Summary:
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 or disease Intervention/treatment Phase
Subclinical Hypothyroidism Drug: Levothyroxine Drug: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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
Study Start Date : May 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothyroidism
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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.



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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

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

Publications:
Responsible Party: Nasmi Niknam, Dr., Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02090907     History of Changes
Other Study ID Numbers: 392349
First Posted: March 18, 2014    Key Record Dates
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