Different Treatment Modalities in the Management of the Painful Crisis in Pediatric Sickle- Cell Anemia

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

November 1, 2019

Primary Completion Date

November 1, 2020

Study Completion Date

December 10, 2020

Conditions
Vaso-occlusive CrisisSickle Cell DiseaseSickle Cell Anemia in Children
Interventions
DRUG

Omega 3

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

DRUG

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."

DRUG

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."

DRUG

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."

DRUG

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.

DRUG

Folic Acid Supplementation

Folic Acid dose of 0.5 to 1 mg daily for 3 to 4 weeks until definite hematologic response

DRUG

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.

PROCEDURE

blood transfusion session

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

Trial Locations (4)

Unknown

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

All Listed Sponsors
collaborator

Benisuef university hospital

UNKNOWN

collaborator

University of Arizona

OTHER

collaborator

Maternity and Children Hospital, Makkah

OTHER

lead

Beni-Suef University

OTHER

NCT04301336 - Different Treatment Modalities in the Management of the Painful Crisis in Pediatric Sickle- Cell Anemia | Biotech Hunter | Biotech Hunter