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N-acetylcysteine and vitamin E in transfusion dependent ß-thalassemia

Evaluation of the efficacy of N-Acetylcysteine and vitamin E supplementation on oxidative stress status in patients with transfusion-dependent ß-thalassemia

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20081207001494N3
Enrollment
75
Registered
2019-07-02
Start date
2019-07-23
Completion date
Unknown
Last updated
2019-08-26

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

Conditions

Transfusion dependent beta-thalassemia. Transfusion dependent beta-thalassemia

Interventions

Intervention 1: Intervention group: The N-Acethyl Cystein Group. Intervention 2: Intervention group: ?The vitamin E group. Intervention 3: Control group: No treatment.

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Drug adverse events. Timepoint: Monthly. Method of measurement: Physical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSezaneh Haghpanah

Shiraz University of Medical Sciences

haghpanah@sums.ac.ir+98 71 3612 2263

Outcome results

None listed

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