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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

November 1, 2019

Primary Completion Date

December 20, 2020

Study Completion Date

January 20, 2021

Conditions
Iron OverloadOxidative StressThalassemia Major
Interventions
DRUG

Omega 3

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

DRUG

Nigella Sativa Oil

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

DRUG

Hydroxyurea

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

DRUG

Honey

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

DRUG

Deferoxamine

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.

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-Suef 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

Maternity and Children Hospital, Makkah

OTHER

collaborator

Beni-Suef Health insurance hospital

UNKNOWN

collaborator

University of Arizona

OTHER

lead

Beni-Suef University

OTHER

NCT04292314 - Hydroxy Urea, Omega 3, Nigella Sativa,Honey on Oxidative Stress and Iron Chelation in Pediatric Major Thalassemia | Biotech Hunter | Biotech Hunter