Effect of green tea consumption in the treatment of patients with beta-thalassemia major
Phase 3
- Conditions
- Beta thalassaemia.Beta thalassaemia
- Registration Number
- IRCT201403303664N10
- Lead Sponsor
- Vice chancellor for research, Tabriz University of Medical Sience
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
Beta-thalassemia disease; usage of chelator drug deferoxamine; not suffering from viral hepatitis B and C; having over 18 years of age and not use of any antioxidant supplements 3 months before intervention.
Exclusion criteria: Absence of any of the above conditions will result in withdrawal from the study subjects
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Iron stores levels ( Iron serum, Ferritin serum, Transferrin Saturation and TIBC). Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry for Iron serum and TIBC, ELISA assay for ferritin and Iron serum/TIBC* 100 for Transferrin Saturation.;Liver enzymes (AST, ALT). Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Lipid profiles (TC, TG, LDL-C, HDL-C). Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: Enzymatic methods for TC,TG and HDL-C For LDL-C : Freidwald’s formula: LDL-C = TC- HDL-C - (TG/5).;Serum Total Antioxidant Capacity. Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Serum Malondialdehyde (MDA). Timepoint: Baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.
- Secondary Outcome Measures
Name Time Method Macronutrients intake. Timepoint: Before and after 8 weeks intervention. Method of measurement: 24-h Recall Questionnaire.;Anthropometric index(weight and Body Mass Index). Timepoint: Before and after 8 weeks intervention. Method of measurement: Analogue scale for weight and weight (Kg) /Square Height for Body Mass Index.