Subclinical Hypothyroidism. Subclinical iodine-deficiency hypothyroidism
Conditions
Interventions
Intervention 1: Levothyroxine in active group with dose adjustment to achieve a serum TSH level between 0.3-3.5 mU/L. Levothyroxine will be used by oral in fasting state for 12 months. Intervention 2
Treatment - Drugs
Placebo
Levothyroxine in active group with dose adjustment to achieve a serum TSH level between 0.3-3.5 mU/L. Levothyroxine will be used by oral in fasting state for 12 months
Placebo in control group, 1 tablet daily by oral root in fasting state for 12 months.
Sponsors
Endocrine and Metabolism research center of shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
17 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Patients with subclinical hypothyroidism Exclusion criteria: Clinical hypothyroidism; Pregnancy; thyroid or Anti-thyroid medication till 1 month before study; history of coronary artery disease and arrhythmia and non cooperative patients
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Thyroid Stimulating Hormone. Timepoint: At the begining, 6 weeks after and then every 3 mo. Method of measurement: IRMA method. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sex hormone binding globulin(SHBG). Timepoint: Baseline and at the end of study. Method of measurement: Radio Immuno Assay.;Creatin Phospho Kinase(CPK). Timepoint: Baseline and at the end of study. Method of measurement: Enzymatic Colorimetry.;Body mass index(BMI). Timepoint: Baseline and at the end of study. Method of measurement: Calculation: Weight(kg)/Height2(m).;Hypothyroidism clinical score. Timepoint: Baseline and at the end of study. Method of measurement: Modified Bilewicz questionnaire.;Psychomotor tests. Timepoint: Baseline and at the end of study. Method of measurement: Coughlan, Ravon and Hospital anexiety depression scales( HADS) tests.;Serum concentration of thyroid antibodies. Timepoint: Baseline and at the end of study. Method of measurement: Radio Immuno Assay(RIA).;Lipids. Timepoint: Baseline and at the end of study. Method of measurement: Enzymatic colorimetry.;Apolipoproteines A and B. Timepoint: Baseline and at the end of study. Method of measurement: Torbidometry.;Paraxonase. Timepoint: Baseline and at the end of study. Method of measurement: Spectrophotometry.;Prolactin. Timepoint: Baseline and at the end of study. Method of measurement: Radio Immuno Assay.;Calcium. Timepoint: Baseline and at the end of study. Method of measurement: Chemical colorimetry.;Alkaline Phosphatase. Timepoint: Baseline and at the end of study. Method of measurement: Chemical colorimetry.;Sodium. Timepoint: Baseline and at the end of study. Method of measurement: Flame Photometry.;Phosphorous. Timepoint: Baseline and at the end of study. Method of measurement: Chemical colorimetry.;Lipoprotein A. Timepoint: Baseline and at the end of study. Method of measurement: Autoanalysis.;Systolic and Diastolic blood pressure. Timepoint: At baselina and at the end of study. Method of measurement: Standard method in Mm/Hg. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSedigheh Moradi
Tehran University of Medical Sciences
Outcome results
None listed