A Phase 2/3 interventional study of Levothyroxine and Placebo in Subclinical Hypothyroidism, sponsored by Isfahan University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-03-18.
Sponsored by Isfahan University of Medical Sciences · Phase 2/3, Interventional, and Treatment
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.
247 studies on the registry are indexed under Hypothyroidism; 57 are open to participants now.
This study's enrollment of 50 is below the median of 78 across 128 interventional studies indexed under Hypothyroidism.
Browse Hypothyroidism studies →Isfahan University of Medical Sciences is the lead sponsor of 145 studies on the registry; 8 are open to participants now.
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In the treatment group, daily doses of 100 mg of Levothyroxine will be administered every morning, half an hour before breakfast.
Drug: Levothyroxine
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
Change from baseline flow-mediated dilation at 2 months
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.
Time frame: At baseline and then 2 months after treatment
Change from baseline intima-media thickness at 2 months
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.
Time frame: At baseline and then 2 months after treatment
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Isfahan University of Medical Sciences