Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism
|ClinicalTrials.gov Identifier: NCT02090907|
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : March 18, 2014
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
In the treatment group, daily doses of 100 mg of Levothyroxine will be administered every morning, half an hour before breakfast.
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090907
|Iran, Islamic Republic of|
|Khorshid endocrinology clinic|
|Isfahan, Iran, Islamic Republic of|
|Principal Investigator:||Nasmi Niknam, M.D.||Isfahan University of Medical Sciences|