50 patients from each participating hospital that will receive Omega-3 supplementation (300-400mg EPA & 200-300mg DHA) per day for 8 consecutive months up to 10 months.
in addition to experimental treatment this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods till efficacy of experimental treatment proved.

50 patients from each participating hospital that will receive Nigella sativa supplementation (1g black seed oil contain 1% thymoquinone) per day for 8 consecutive months up to 10 months.
in addition to experimental treatment this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods till efficacy of experimental treatment proved.

50 patients from each participating hospital that will receive hydroxyurea medication (5 to 15mg/kg) per day for 8 consecutive months up to 10 months.
in addition to the experimental treatment, this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods until the efficacy of experimental treatment proved.

50 patients from each participating hospital that will receive natural honey(2.5 mg/kg dissolved in 250 ml water) per day for 8 consecutive months up to 10 months.
in addition to the experimental treatment, this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods until the efficacy of experimental treatment proved.

50 patients from each participating hospital that will receive the ordinary treatment of iron chelator agent of deferoxamine or deferasirox (SubQ infusion: 20 to 40 mg/kg/day over 8 to 12 hours, 6 to 7 nights per week, maximum daily dose: 40 mg/kg/day)for 8 consecutive months up to 10 months.
in addition to iron chelator agent, this group receive regular blood transfusion session.

Iron Overload

Oxidative Stress

Thalassemia Major

Omega-3 supplementation (300-400mg EPA & 200-300mg DHA) per day for 8 consecutive months up to 10 months

Omega 3

Nigella sativa supplementation (1g black seed oil contain 1% thymoquinone) per day for 8 consecutive months up to 10 months

Nigella Sativa Oil

hydroxyurea medication (5 to 15mg/kg) per day for 8 consecutive months up to 10 months.

Hydroxyurea

Natural honey(2.5 mg/kg dissolved in 250 ml water) per day for 8 consecutive months up to 10 months.

Honey

deferoxamine (SubQ infusion: 20 to 40 mg/kg/day over 8 to 12 hours, 6 to 7 nights per week, maximum daily dose: 40 mg/kg/day)for 8 consecutive months up to 10 months.

Deferoxamine

Regular blood transfusion session based on patient hematological profile starts from one session every 2 weeks.

blood transfusion session

Faculty of medicine, Beni-suef univeristy - Beni-Suef university hospital

Faculty of Pharmacy, Beni-Suef university

Health insurance hospital

Maternity and Children hospital

Hydroxy Urea, Omega 3, Nigella Sativa,Honey on Oxidative Stress and Iron Chelation in Pediatric Major Thalassemia

Impact of Combination Therapy Between Hydroxy Urea, Omega 3, Nigella Sativa and Honey on Antioxidant-oxidant Status and Reduction of Iron Overload in Pediatric Major Thalassemia

plasma F 2 -isoprostanes Picograms Per Millilitre measured by high pressure liquid chromatography assay

Total cholesterol milligrams per deciliter

Serum total iron micrograms per decilitre

C-reactive protein milligrams per deciliter

Total Iron Binding Capacity micrograms per decilitre

mean corpuscular hemoglobin (MCH) Picograms Per Millilitre

Chelation activity of Ferric - thymoquinone complex in percentage measured by high pressure liquid chromatography coupled with gaschromatography - mass spectroscopy analysis

Chelation activity of Ferrous - thymoquinone complex in percentage measured by high pressure liquid chromatography coupled with gaschromatography- mass spectroscopy analysis

Lactic acid dehydrogenase unit per litter

hemoglobin- F level in gram per deciliter

Reticulocyte absolute count in a cubic milliliter of blood

White blood cells count in a cubic milliliter of blood

Mohamed Medhat Abdelwahab Gamaleldin

Dr.Mohamed Medhat Abdelwahab Gamaleldin

Beni-Suef University

Maternity and Children Hospital, Makkah

Department of clinical pharmacy, faculty of pharmacy, Beni-suef univeristy

Beni-Suef Health insurance hospital

University of Arizona

College of Pharmacy,Department of Pharmacy Practice,University of Arizona

Four experimental groups, one control group.
Each experimental group receives different experimental treatments plus traditional treatment in the hospital and the control group receives only traditional treatment.

30 Patients will be treated with combined DFP and deferasirox.

Patients will be treated for 6 days with a combination of deferoxamine and DFP

Beta-thalassemia Major

Sickle Cell Disease

Iron Hemosiderosis

Drug: Ferriprox It will be given orally in the morning Other Name: DFP Initial dose 25/mg/kg 3 times/d (better tolerated if started and then built up over 4 weeks).
Dose may be increased up to 100mg/kg/day guided by serum ferritin. Agranulocytosis risk 1-2%. Monitor TLC and granulocytic count / 2weeks. Patients need to be continually educated about this risk, know that they must stop DFP if they have a fever or infection.
Drug: Deferasirox will be orally administered at a dose of 20 mg/kg once daily at evening for 5 days.
Other Name: ICL670

DFP (ferriprox) and deferasirox (ICL 670)

Drug: Deferoxamine It will be administered subcutaneously over 8 hours for 5 days at a dose of 40 mg/kg.
Other Name: Desferal, DFO Drug: DFP DFP: will be orally administered at a dose of 75mg/kg orally in 3 divided doses for 7 days

DFP, DFO

Pediatric Hematology clinic, Ain Shams University

Study Of Efficacy,Safety of Combined Deferasirox and Deferiprone Versus Combined Deferiprone and Desferal In Conditions of Iron Overload

A Prospective Randomized Comparative Study of Efficacy and Safety of Combined Deferiprone (DFP) and Deferasirox Versus DFP and Desferrioxamine (DFO) Therapy in Diseases With Severe Iron Overload

• The primary outcome measure is to measure the change in serum ferritin level from baseline in the 2 combination therapy.

• The secondary outcome measure is to determine the number of patients who will develop adverse reactions upon administering the drugs in combination.

beta-thalassemia/karščiavimas

Hydroxy Urea, Omega 3, Nigella Sativa,Honey on Oxidative Stress and Iron Chelation in Pediatric Major Thalassemia

Study Of Efficacy,Safety of Combined Deferasirox and Deferiprone Versus Combined Deferiprone and Desferal In Conditions of Iron Overload

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