NCT04292314 is a Phase 2, PHASE3 clinical trial of Omega 3 in Iron Overload, sponsored by Beni-Suef University.

Who is sponsoring NCT04292314?

NCT04292314 is sponsored by Beni-Suef University.

What drugs are being tested in NCT04292314?

Interventions in NCT04292314: Omega 3, Nigella Sativa Oil, Hydroxyurea, Honey, Deferoxamine, blood transfusion session.

What condition does NCT04292314 study?

NCT04292314 studies Iron Overload, Oxidative Stress, Thalassemia Major.

Is NCT04292314 still recruiting?

NCT04292314 is currently completed. Last updated 27 January 2021.

Last reviewed 2021-01-27 · How we verify

NCT04292314

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2, PHASE3 Last updated 27 January 2021

What this trial tests

Phase 2, PHASE3 trial testing Omega 3 in Iron Overload in 350 participants. Completed in 20 January 2021.

Timeline

1 November 2019

Primary endpoint
20 December 2020

20 January 2021

Quick facts

Lead sponsor	Beni-Suef University
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	350
Start date	1 November 2019
Primary completion	20 December 2020
Estimated completion	20 January 2021
Sites	4 locations across Saudi Arabia, Egypt

Drugs / interventions tested

Omega 3 — full drug profile →
Nigella Sativa Oil — full drug profile →
Hydroxyurea — full drug profile →
Honey — full drug profile →
Deferoxamine (DEFEROXAMINE) — full drug profile →
blood transfusion session

Conditions studied

Iron Overload — all drugs for Iron Overload →
Oxidative Stress — all drugs for Oxidative Stress →
Thalassemia Major — all drugs for Thalassemia Major →

Sponsor

Beni-Suef University

Who can join

Adults 7 to 15, any sex, with Iron Overload or Oxidative Stress. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Omega 3

Trials testing the same drug.

NCT05774665 — Specialized Pro-resolving Lipid Mediators and Treatment Resistant Depression · Phase 2 · active not recruiting
NCT06555705 — Effect of Omega 3 Supplementation on the Heart Rate Variability in Obese Children · NA · completed
NCT07138131 — Impact of Omega 3 in Treatment of Inappropriate Sinus Tachycardia · NA · completed
NCT06463535 — Effects of Omega-3 as an Adjunct to Non-Surgical Periodontal Therapy on Chemerin Level in Periodontitis Patients With Di · NA · completed
NCT04411615 — Effect of Re-esterified Triglyceride (rTG) Form Omega-3 Supplements on Dry Eye Following Cataract Surgery · NA · unknown

Other recruiting trials for Iron Overload

Currently open trials in the same condition.

NCT06596746 — Neurodegenerative Diseases Progression Markers (MARKERS-NDD) · recruiting
NCT06146608 — Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption · recruiting
NCT04198545 — Ethnic Differences in Iron Absorption (FeGenes) · active not recruiting

Other Beni-Suef University trials

Trials by the same sponsor.

NCT07536347 — Effect of Adding PNF to IMT on Weaning Off MV · NA · not yet recruiting
NCT07494240 — Effects of Changes in Driving Pressure on Intraoperative Pulmonary Dynamic Compliance and PaO₂/FiO₂ Ratio in Laparoscopi · NA · not yet recruiting
NCT07506499 — Cardiac Rehabilitation in Decompensated Heart Failure · NA · recruiting
NCT07482631 — Robotic Glove Training on Hand Function in Unilateral Cerebral Palsy · NA · not yet recruiting
NCT07509736 — Effect of Pulmonary Rehabilitation in Females With Acute Exacerbation of COPD Induced by Biomass Fuel Smoke · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04292314 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Beni-Suef University
Last refreshed: 27 January 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04292314.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing