Clinical trial NCT01752153: Immunomodulatory Effects of Silymarin in Patients With Beta-Thalassemia Major
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immune Abnormalities
Keywords: Focus
immunomodulatory effect
of silymarin
on cell mediated immunity
Beta-Thalassemia
major patients.
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 25
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A wide spectrum of immune abnormalities has been described by numerous studies involving β-thalassemic patients with multiple transfusions. The abnormalities observed are both quantitative and functional, and concern several components of the immune response. Flavonoids are phenolic compounds widely distributed in plants, which were reported to exert multiple biological effects, including antioxidant and free radical scavenging abilities. Silymarin, a flavonolignan complex isolated from milk thistle (Silybum marianum L. Gaertn), have been classified as cytoprotective, antioxidant, anti-inflammatory, and especially as hepatoprotective agents. Silymarin is already being used clinically for treatment of liver diseases.It is considered safe and well-tolerated, with reported adverse events similar to placebo. Several studies have also reported immunomodulatory actions of silymarin. It increases lymphocyte proliferation, interferon gamma, interleukin (IL)-4 and IL-10 secretions by stimulated lymphocytes in a dose-dependent manner. It has been shown that in vitro treatment of peripheral blood mononuclear cells with silymarin causes restoration of the thiol status and increases in T cell proliferation and activation. Because reactive oxygen species and iron overload play important roles in the pathophysiology of thalassemia, silymarin may be an effective therapy due to its antioxidant, immunomodulatory, cytoprotective and iron chelating activities. The present study designed to investigate the therapeutic activity of orally administered silymarin for treatment of β-thalassemia major, a well-known and prevalent disease in Iran, which is associated with oxidative stress, iron overload and immune abnormalities.


Eligibility criteria: Inclusion Criteria:

* Homozygous beta-thalassemia major
* Regularly blood transfusion
* Iron chelation therapy with subcutaneous desferrioxamine (DFO)40.0 mg/Kg/day for 5-7 days/week

Exclusion Criteria:

* Chronic hepatitis B infection
* Active hepatitis C infection
* A history of a positive HIV test
* Chronic renal or heart failure
* Iron chelation therapy with deferiprone
* Pregnancy
* Gastrointestinal conditions preventing absorption of an oral medication o
* noncompliance with prescribed therapy

Primary outcomes:
measure: Change from Baseline in T cell proliferation
timeFrame: 12 weeks
measure: Changes from baseline the percentage of lymphocyte subsets
timeFrame: 12 weeks
measure: Changes from baseline the production of cytokines in activated T cells
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Department of Immunology, School of Medicine, Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: Shiraz University of Medical Sciences
name: Zahra Amirghofran, PhD
role: STUDY_DIRECTOR
References: