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IRCT20250502065563N3 IRCT 2026-10-16 Dezfoul University of Medical Sciences The effect of glycine in patients with hyperthyroidism Investigation of the Effect of Glycine in Patients with Hyperthyroidism Treated with Methimazole: A Two-Arm, Placebo-Controlled, Randomized Clinical Trial 2026-12-22 anticipated 60 Pending https://irct.ir/trial/94097 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 60 eligible patients will be randomly allocated in a 1:1 ratio to the intervention and control groups after obtaining informed consent and completing the methimazole stabilization period. The unit of randomization will be the individual patient. Randomization will be performed using variable block sizes. An independent individual, not involved in trial implementation, will generate the random allocation sequence using computer-generated random numbers. The allocation list will remain confidential, and allocation concealment will be maintained to prevent the person enrolling participants from knowing upcoming assignments, Blinding description: In this study, participants, outcome assessors, and the statistical analyst will be blinded to treatment allocation. Glycine and placebo capsules will be identical in appearance, color, size, and packaging and will be coded. Allocation codes will remain confidential until completion of the final data analysis. 2 Hyperthyroidism. Intervention 1: Intervention group: Participants in this group (n=30) will receive oral glycine supplementation at a dose of 1 gram once daily, 1–2 hours before bedtime, for four consecutive weeks, in addition to standard methimazole therapy at a daily dose of 10–20 mg as prescribed by their physician. Supplementation will begin at least four weeks after initiation of methimazole treatment. Intervention 2: Control group: Participants in this group (n=30) will receive standard methimazole therapy at a daily dose of 10–20 mg as prescribed by their physician. They will also receive an oral placebo matched to glycine in appearance, color, size, and packaging, once daily, 1–2 hours before bedtime, for four consecutive weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Ali Akbar Oroojan
School of Medicine, Dezful University of Medical Sciences, Azadegan Street, Dezful, Iran.
Dezful Iran (Islamic Republic of) 6461653476 +98 61 4242 2710 aliakbar_oroojan@yahoo.com Dezfoul University of Medical Sciences scientific Ali Akbar Oroojan
School of Medicine, Dezful University of Medical Sciences, Azadegan Street, Dezful, Iran.
Dezful Iran (Islamic Republic of) 6461653476 +98 61 4242 2710 aliakbar_oroojan@yahoo.com Dezfoul University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 60 years. Clinically and laboratory-confirmed diagnosis of hyperthyroidism. Receiving methimazole treatment at a daily dose of 10–20 mg. At least four weeks since initiation of methimazole treatment. Ability to complete the study questionnaires. Provision of written informed consent to participate in the study. 18 years 60 years Both Presence of severe liver, kidney and heart disease at the time of screening. Pregnancy at the time of screening and prior to study entry. E05 Thyrotoxicosis [hyperthyroidism] Treatment - Drugs Placebo Intervention group: Participants in this group (n=30) will receive oral glycine supplementation at a dose of 1 gram once daily, 1–2 hours before bedtime, for four consecutive weeks, in addition to standard methimazole therapy at a daily dose of 10–20 mg as prescribed by their physician. Supplementation will begin at least four weeks after initiation of methimazole treatment. Control group: Participants in this group (n=30) will receive standard methimazole therapy at a daily dose of 10–20 mg as prescribed by their physician. They will also receive an oral placebo matched to glycine in appearance, color, size, and packaging, once daily, 1–2 hours before bedtime, for four consecutive weeks. Change in anxiety score assessed using the seven-item Generalized Anxiety Disorder questionnaire. Timepoint: At baseline, before the intervention, and at the end of the fourth week after initiation of glycine or placebo administration. Method of measurement: The seven-item Generalized Anxiety Disorder questionnaire, with a total score ranging from 0 to 21, where higher scores indicate greater anxiety severity. Change in sleep quality score assessed using the Pittsburgh Sleep Quality Index. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Pittsburgh Sleep Quality Index questionnaire, with a total score ranging from 0 to 21; higher scores indicate poorer sleep quality. Change in mean fatigue severity score assessed using the Fatigue Severity Scale. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Fatigue Severity Scale consisting of nine items rated on a seven-point scale; the final score is calculated as the mean of the nine item scores. Change in serum cortisol concentration. Timepoint: At baseline and at the end of the fourth week, between 7:00 and 9:00 AM. Method of measurement: Measurement of serum cortisol concentration using the enzyme-linked immunosorbent assay or the standard method employed by the central laboratory. Change in heart rate measured in beats per minute. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Measurement of heart rate using a calibrated digital blood pressure monitor after at least five minutes of seated rest. Changes in complete blood count parameters. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Complete blood count testing using an automated hematology analyzer. Change in serum C-reactive protein concentration. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Measurement of serum C-reactive protein concentration using a standard laboratory assay. Changes in serum thyroid-stimulating hormone, free thyroxine, and triiodothyronine levels. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Measurement of serum thyroid hormone concentrations using the enzyme-linked immunosorbent assay. Changes in serum alanine aminotransferase and aspartate aminotransferase activities. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Measurement of liver enzyme activities using standard enzymatic colorimetric assays and an automated biochemistry analyzer. Changes in systolic and diastolic blood pressure. Timepoint: At baseline and at the end of the fourth week of intervention. Method of measurement: Measurement of systolic and diastolic blood pressure using a calibrated digital blood pressure monitor after at least five minutes of seated rest. The mean of two consecutive measurements will be recorded in mmHg. Dezfoul University of Medical Sciences Approved 2026-10-07 Ethics committee of Dezful University of Medical Sciences School of Medicine, Dezful University of Medical Sciences, Azadegan Street, Dezful, Iran. Dezful Khouzestan Iran (Islamic Republic of)