350
Participants
Start Date
November 1, 2019
Primary Completion Date
November 1, 2020
Study Completion Date
December 10, 2020
Omega 3
Omega-3 supplementation (300-400mg EPA \& 200-300mg DHA) per day for 8 consecutive months up to 10 months
Vit D
"50 patients from each participating hospital that will receive Vit-D medication (1500 IU to 3500 IU ) per day for 8 consecutive months up to 10 months.~in addition to the experimental treatment, this group will receive the traditional treatment of hydroxyurea, Folic acid, pain killer plus regular blood transfusion with a dose de-escalation methods till efficacy of experimental treatment proved."
Zinc sulfate
"50 patients from each participating hospital that will receive Zinc supplements (15 mg to 50 mg ) per day for 8 consecutive months up to 10 months.~in addition to the experimental treatment, this group will receive the traditional treatment of hydroxyurea, Folic acid, pain killer plus regular blood transfusion with a dose de-escalation methods till efficacy of experimental treatment proved."
Statins (Cardiovascular Agents)
"50 patients from each participating hospital that will receive Simvastatin orally (20 mg to 40 mg ) per day for 8 consecutive months up to 10 months.~in addition to the experimental treatment, this group will receive the traditional treatment of hydroxyurea, Folic acid, pain killer plus regular blood transfusion with a dose de-escalation methods till efficacy of experimental treatment proved."
Hydroxy Urea
50 patients from each participating hospital that will receive the ordinary treatment of Hydroxyurea (20 mg/kg/day) with monitoring blood count every 2 weeks maximum daily dose: (40 mg/kg/day) for 8 consecutive months up to 10 months.
Folic Acid Supplementation
Folic Acid dose of 0.5 to 1 mg daily for 3 to 4 weeks until definite hematologic response
Morphine Sulfate
Morphine medication as a pain killer is administered, if Patient weight \<50 kg: Opioid naïve: Initial: 0.05 mg/kg/dose; usual maximum initial dose: 1 to 2 mg/dose.
blood transfusion session
Regular blood transfusion session based on patient hematological profile starts from one session every 2 weeks.
Faculty of medicine, Beni-suef univeristy - Beni-Seuf university hospital, Banī Suwayf
Faculty of Pharmacy, Beni-Suef university, Banī Suwayf
Health insurance hospital, Banī Suwayf
Maternity and Children hospital, Mecca
Benisuef university hospital
UNKNOWN
University of Arizona
OTHER
Maternity and Children Hospital, Makkah
OTHER
Beni-Suef University
OTHER