acetylcysteine and vitamin E in transfusion dependent ß-thalassemia

Phase 3

Recruiting

• Conditions: D56.1; Transfusion dependent beta-thalassemia.; Transfusion dependent beta-thalassemia

• Registration Number: IRCT20081207001494N3
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

All patients with transfusion-dependent beta-thalassemia above 18 years old who were diagnosed by clinical history, and hemoglobin electrophoresis.
Receiving regular blood transfusion (15 cc/kg body weight with interval of 3-4 weeks to maintain hemoglobin levels above 9.5 g/dl)
Treating by at least one or combination of iron chelation therapy agents including deferasirox (DFX), deferiprone (DFP), and deferoxamine (DFO).

Exclusion Criteria

No desire to participate in the study
Being positive for hepatitis B, C or HIV
Pregnancy
Presentation of any acute infectious disease
Narcotic addiction
Under treatment with nitroglycerine or other related drugs
Asthma
Known allergy to NAC

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum total oxidant status (TOS). Timepoint: At baseline and at the end of the study. Method of measurement: Blood sampling and using specific kit.;Total antioxidant capacity (TAC). Timepoint: At baseline and at the end of the study. Method of measurement: Blood sampling and using specific kit.;Hemoglobin levels. Timepoint: At baseline and at the end of the study. Method of measurement: Blood sampling.;Serum ferritin levels. Timepoint: At the beginning of the study and after three months. Method of measurement: Blood sampling.

Secondary Outcome Measures

Name	Time	Method
Drug adverse events. Timepoint: Monthly. Method of measurement: Physical examination.