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

Summary

The aim of the present study is evaluating the strength of combination therapy of hydroxy urea, omega 3, nigella sativa and honey on antioxidant-oxidant status (OXIDATIVE STRESS) in response to reactive oxygen species production (LIPID PEROXIDATION) and their effect on iron intoxication (IRON CHELATION) in pediatric major thalassemia.

Conditions

• Iron Overload
• Oxidative Stress
• Thalassemia 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.

Sponsors & Collaborators

• Maternity and Children Hospital, Makkah

  collaborator OTHER

• Beni-Suef Health insurance hospital

  collaborator UNKNOWN

• University of Arizona

  collaborator OTHER

• Beni-Suef University

  lead OTHER

Principal Investigators

• IVO IBRAHAM [Prof of Pharmacy, Clinical Translational Sciences], Ph.D. · University of Arizona, College of Pharmacy

• AHMED A ALBERRY [Assistant prof of clinical pharmacology], Ph.D. · Beni-Suef University, Faculty of medicine

• RAGHDA R SAYED [Lecturer of Clinical Pharmacy], Ph.D. · Beni-Suef University, Faculty of Pharmacy

• MOHAMED M ABDELWAHAB GAMALELDIN, Ph.D Student · Beni-Suef University, Faculty of Pharmacy

• Mohamed H Meabad [Prof of Pediatrics], M.D · Beni-Suef university, Faculty of medicine

• Ahmed F Mahmoud Hussein, MS.c · Beni-Suef Health insurance hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-01

Primary Completion

2020-12-20

Completion

2021-01-20

Countries

• Egypt
• Saudi Arabia

Study Locations