Evaluation of the combination therapy with L-levothyroxine and L-triiodothyronine in hypothyroid patients

Comparing the effect of monotherapy with L-levothyroxine compared to combination therapy with L-levothyroxine and L-triiodothyronine on lipid profile of hypothyroid patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201310204849N4

Enrollment

Registered

2013-12-06

Start date

2013-12-11

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypothyroidism. Disorders of thyroid gland

Interventions

Intervention 1: Intervention group 1: Monotherapy with levothyroxine 100 microgram once daily for 24 weeks. Intervention 2: Intervention group 2: Combination therapy with levothyroxine 75 microgram pl

Treatment - Drugs

Intervention group 1: Monotherapy with levothyroxine 100 microgram once daily for 24 weeks

Intervention group 2: Combination therapy with levothyroxine 75 microgram pluse triiodothyronine 12.5 microgram once daily for 24 weeks

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: New cases of hypothyroidism; Do not consumption of any thyroid hormones in the past three months Exclusion criteria: Use of any Anti depressant agents; OCP; Anti hyperlipidemic agents; Orliestat; Breast feeding and pregnancy; Opium addiction; Myxedema coma; Use of any drug that interfere with thyroid hormones metabolism; the Patients that registered for other studies in the last month; coronary artery disease

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Lipid profile. Timepoint: Before intervention and 12 and 24 weeks after the intervention. Method of measurement: quantitative detective kits in human serum or plasma with photometric method.;Body mass index. Timepoint: Before intervention and 12 and 24 weeks after the intervention. Method of measurement: weight (Kg)/ height(m)2.;Blood pressure. Timepoint: Before intervention and 12 and 24 weeks after the intervention. Method of measurement: Manometer.;Quality of life. Timepoint: Before intervention and 12 and 24 weeks after the intervention. Method of measurement: Questionnaire.;TSH. Timepoint: Before intervention and 12 and 24 weeks after the intervention. Method of measurement: Non competitive immunoradiometric assay (IRMA) for quantitative detection of TSH in human serum or plasma with gamma counter.	—

Measure

Time frame

Lipid profile. Timepoint: Before intervention and 12 and 24 weeks after the intervention. Method of measurement: quantitative detective kits in human serum or plasma with photometric method.;Body mass index. Timepoint: Before intervention and 12 and 24 weeks after the intervention. Method of measurement: weight (Kg)/ height(m)2.;Blood pressure. Timepoint: Before intervention and 12 and 24 weeks after the intervention. Method of measurement: Manometer.;Quality of life. Timepoint: Before intervention and 12 and 24 weeks after the intervention. Method of measurement: Questionnaire.;TSH. Timepoint: Before intervention and 12 and 24 weeks after the intervention. Method of measurement: Non competitive immunoradiometric assay (IRMA) for quantitative detection of TSH in human serum or plasma with gamma counter.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Amir Ziaee

Metabolic Diseases Research Center, Qazvin University of Medical Sciences, Qazvin, Iran

aziaee1963@yahoo.com, aziaee@qums.ac.ir+98 28 1336 0084

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026