Nutritional, Metabolic, Endocrine
Conditions
Interventions
AZA50
AZA 100
control
Sponsors
Alexandria University
Alexandria University student hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Aged 18-75 years. b. Interested and willing to participate in the study. c. newly diagnosed Graves' disease with severe hyperthyroidism and do not be treated with anti-thyroid medications. Severe hyperthyroidism was defined in patients who have one or more of the following items: • Those who are extremely symptomatic especially with heart rate > 120 b/min, got hyperthyroid heart disease, or loss of weight > 10 kg, • patients who have free T4 or free T3 estimates 2–3 times the upper limit of normal. (FT4 = 3.6 ng/dL,or FT3 = 8.4 pg/mL, respectively) d. If a female in the childbearing period must: i. neither be pregnant nor breastfeeding nor attempting to conceive. ii. use a highly effective method of contraception throughout the entire duration of the study and for at least 90 days after the last dose of azathioprine. iii. A serum pregnancy test will be performed at the first screening visit.
Exclusion criteria
Exclusion criteria: a- End stage diseases. b- Live vaccines within the past 3 months c- Haemoglobin concentration 3. g- Treatment with steroids (administered via the oral and/or parenteral routes) or adrenocorticotropic hormone with the exception of inhaled steroids within the three months prior to Study Day 1. h- Patients require urgent treatment of thyrotoxicosis. i. Significant cardiac disease and/or atrial fibrillation ii. Symptoms and signs of thyroid storm. iii. Large and compressive goiters causing localized symptoms such as difficulty swallowing or breathing i- The use of azathioprine, or participation in any Clinical Trial within three months prior to Study Day 1. j- Treatment with any cytokine or anti-cytokine therapy within three months prior to Study Day 1. k- Inadequate liver function, defined by total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase > 3 times the upper limit of the normal values at the screening visit. l- Subject with any significant medical illness or psychiatric condition would preclude participation in the study or impair the ability to give informed consent; any other clinically apparent autoimmune disease. M- pregnant or lactating females. Also, females attempting to conceive will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of remission Complete remission: is defined as keeping euthyroid with negative TRAB and without receiving any ATD for at least 12 months. Partial remission: is defined as keeping euthyroid with receiving low-dose MMI (i.e 5mg/d) for at least 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The duration of treatment required for serum thyroid hormones concentration (TSH, FT3, and FT4) to normalize (0.39 – 4.16 mIU/L, 1.4-4.2 pg/mL, and 0.8-1.8 ng/dL, respectively).;The rate of relapse (recurrence of hyperthyroidism) within a follow-up of at least 12 months after cessation of treatment;Change in total thyroid volume ;The medical costs in all groups;safety and tolerability of combination of AZA and carbimazole | — |
Countries
Egypt
Contacts
Public ContactRamy Ghazy
Assistant Lecturer of Tropical Health
Outcome results
None listed