Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism

Isfahan University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Subclinical Hypothyroidism

Treatments: Drug: Placebo; Drug: Levothyroxine

Study type: Interventional

Funder types: Other

Identifiers

NCT02090907

392349

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Levothyroxin

Experimental group

Description:

In the treatment group, daily doses of 100 mg of Levothyroxine will be administered every morning, half an hour before breakfast.

Treatment:

Drug: Levothyroxine

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo