Iron OverloadPhase 2/3NCT04292314
Hydroxy Urea, Omega 3, Nigella Sativa,Honey on Oxidative Stress and Iron Chelation in Pediatric Major Thalassemia
A Phase 2/3 study testing Omega 3, Nigella Sativa Oil and Hydroxyurea in people with Iron Overload and Oxidative Stress, run by Beni-Suef University at 4 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Iron Overload, Oxidative Stress, Thalassemia Major
- What is being tested?
- Omega 3, Nigella Sativa Oil and Hydroxyurea
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Nov 2019to 20 Jan 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any case with full manifestation of β-THALASSEMIA major disease
- #Aged from 7-15 years old
- # accompanied with ineffective erythropoiesis
- # with low hemoglobin level
- # with iron overload
Who cannot join
- The presence of any other chronic illness.
- Patient age>15 years old or < 7 years old.
- The presence of concomitant myocardial infarction, stroke, acute chest syndrome.
- The patient suffers from any other type of anemia.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Egypt3 sites
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
About this study
Official title: Impact of Combination Therapy Between Hydroxy Urea, Omega 3, Nigella Sativa and Honey on Antioxidant-oxidant Status and Reduction of Iron Overload in Pediatric Major Thalassemia
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.
Read the detailed description
Beta thalassemia is a blood disorder that reduces the production of hemoglobin. Hemoglobin is the iron-containing protein in red blood cells that carries oxygen to cells throughout the body. In people with beta thalassemia, low levels of hemoglobin lead to a lack of oxygen in many parts of the body. Affected individuals also have a shortage of red blood cells (anemia), which can cause pale skin, weakness, fatigue, and more serious complications. People with beta thalassemia are at an increased risk of developing abnormal blood clots. Beta thalassemia is classified into two types depending on the severity of symptoms: thalassemia major (also known as Cooley's anemia) and thalassemia intermedia. Of the two types, thalassemia major is more severe.
Beta-thalassemia syndromes are a group of hereditary blood disorders. It is characterized by reduced beta globin chain synthesis, resulting in reduced Hb in red blood cells (RBC), decreased RBC production and anemia.
Homozygotes for beta-thalassemia may develop either thalassemia major or thalassemia intermedia. Individuals with thalassemia major usually come to medical attention within the first 2 years and require regular blood transfusion to survive.
Affected infants with thalassemia major fail to thrive and become progressively pale. Feeding problems, diarrhea, irritability, recurrent bouts of fever, and enlargement of the abdomen, caused by splenomegaly, may occur. If a regular transfusion program that maintains a minimum Hb concentration of 95-105 g/L is initiated, then growth and development are normal until the age of 10-11 years. After the age of 10-11 years, affected individuals are at risk of developing severe complications related to posttransfusional iron overload, depending on their compliance with chelation therapy.
Complications of iron overload include growth retardation and failure of sexual maturation and also those complications observed in adults with hemachromatosis -associated hereditary hemochromatosis (HH): involvement of the heart (dilated myocardiopathy and pericarditis), liver (chronic hepatitis, fibrosis, and cirrhosis), and endocrine glands (resulting in diabetes mellitus and insufficiency of the parathyroid, thyroid, pituitary, and, less commonly, adrenal glands).
The underlying basis of b-thalassemia pathology is the diminished b-globin synthesis leading to a-globin accumulation and premature apoptotic destruction of erythroblasts, causing oxidative stress-induced ineffective erythropoiesis.
- Conditions
- Iron Overload, Oxidative Stress, Thalassemia Major
- Being tested
- Omega 3, Nigella Sativa Oil, Hydroxyurea, Honey, Deferoxamine
- Keywords
- thymoquinone, omega3, hydroxyurea, pediatric Thalassemia Major, oxidative stress, iron chelation, iron overload, chelation activity of thymoquinone, antioxidant effect of omega3, anti-hemolysis effect of hydroxyurea
- Medical subject headings
- Iron Overload, beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3Drug
Omega-3 supplementation (300-400mg EPA \& 200-300mg DHA) per day for 8 consecutive months up to 10 months
Nigella Sativa OilDrug
Nigella sativa supplementation (1g black seed oil contain 1% thymoquinone) per day for 8 consecutive months up to 10 months
HydroxyureaDrug
hydroxyurea medication (5 to 15mg/kg) per day for 8 consecutive months up to 10 months.
HoneyDrug
Also called Natural honey formulation
Natural honey(2.5 mg/kg dissolved in 250 ml water) per day for 8 consecutive months up to 10 months.
DeferoxamineDrug
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.
blood transfusion sessionProcedure or surgery
Regular blood transfusion session based on patient hematological profile starts from one session every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 experimental group | Experimental | 50 patients from each participating hospital that will receive Omega-3 supplementation (300-400mg EPA \& 200-300mg DHA) per day for 8 consecutive months up to 10 months.
in addition to experimental treatment this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods till efficacy of experimental treatment proved. Receives: Drug: Omega 3; Drug: Deferoxamine; Procedure: blood transfusion session |
| Nigella sativa experimental group | Experimental | 50 patients from each participating hospital that will receive Nigella sativa supplementation (1g black seed oil contain 1% thymoquinone) per day for 8 consecutive months up to 10 months.
in addition to experimental treatment this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods till efficacy of experimental treatment proved. Receives: Drug: Nigella Sativa Oil; Drug: Deferoxamine; Procedure: blood transfusion session |
| Hydroxyurea experimental group | Experimental | 50 patients from each participating hospital that will receive hydroxyurea medication (5 to 15mg/kg) per day for 8 consecutive months up to 10 months.
in addition to the experimental treatment, this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods until the efficacy of experimental treatment proved. Receives: Drug: Hydroxyurea; Drug: Deferoxamine; Procedure: blood transfusion session |
| Natural honey experimental group | Experimental | 50 patients from each participating hospital that will receive natural honey(2.5 mg/kg dissolved in 250 ml water) per day for 8 consecutive months up to 10 months.
in addition to the experimental treatment, this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods until the efficacy of experimental treatment proved. Receives: Drug: Honey; Drug: Deferoxamine; Procedure: blood transfusion session |
| Ordinary hospital treatment group | Active comparator | 50 patients from each participating hospital that will receive the ordinary treatment of iron chelator agent of deferoxamine or deferasirox (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.
in addition to iron chelator agent, this group receive regular blood transfusion session. Receives: Drug: Deferoxamine; Procedure: blood transfusion session |
What is being measured
The primary outcome is the main question the study is designed to answer.
F 2 -isoprostanes pg/mL
plasma F 2 -isoprostanes Picograms Per Millilitre measured by high pressure liquid chromatography assay
Measured: 3 months
Total cholesterol Mg/dl
Total cholesterol milligrams per deciliter
Measured: 10 months
HDL cholesterol Mg/dl
HDL cholesterol milligrams per deciliter
Measured: 10 months
LDL cholesterol Mg/dl
LDL cholesterol milligrams per deciliter
Measured: 10 months
Triglycerides Mg/dl
Triglycerides milligrams per deciliter
Measured: 10 months
Serum total iron mcg/dL
Serum total iron micrograms per decilitre
Measured: 10 months
% transferrin saturation
transferrin saturation percentage
Measured: 10 months
C-reactive protein mg/L
C-reactive protein milligrams per deciliter
Measured: 10 months
Serum Ferritin ng/ml
Serum Ferritin Nanograms per milliliter
Measured: 10 months
Total Iron Binding Capacity (TIBC) mcg/dL
Total Iron Binding Capacity micrograms per decilitre
Measured: 10 months
hemoglobin (Hbg) g/dL
hemoglobin (Hbg) gram/deciliter
Measured: 10 months
mean corpuscular hemoglobin (MCH) pg/ml
mean corpuscular hemoglobin (MCH) Picograms Per Millilitre
Measured: 10 months
leukocytes count μl
leukocytes in microliter
Measured: 10 months
% Chelation activity Fe+++ - thymoquinone complex
Chelation activity of Ferric - thymoquinone complex in percentage measured by high pressure liquid chromatography coupled with gaschromatography - mass spectroscopy analysis
Measured: 3 months
% Chelation activity Fe++ - thymoquinone complex
Chelation activity of Ferrous - thymoquinone complex in percentage measured by high pressure liquid chromatography coupled with gaschromatography- mass spectroscopy analysis
Measured: 3 months
Lactic acid dehydrogenase U/L
Lactic acid dehydrogenase unit per litter
Measured: 10 months
Reticulocyte count %
Reticulocyte count percentage
Measured: 10 months
Hb-F level g/dL
hemoglobin- F level in gram per deciliter
Measured: 10 months
Reticulocyte absolute count
Reticulocyte absolute count in a cubic milliliter of blood
Measured: 10 months
White blood cells count
White blood cells count in a cubic milliliter of blood
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Nov 2019
- Primary completion20 Dec 2020
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron OverloadStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four experimental groups, one control group. Each experimental group receives different experimental treatments plus traditional treatment in the hospital and the control group receives only traditional treatment.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- Maternity and Children Hospital, Makkah, Beni-Suef Health insurance hospital, University of Arizona
- Responsible party
- Principal investigator, Mohamed Medhat Abdelwahab Gamaleldin, Beni-Suef University
- Investigators
- IVO IBRAHAM [Prof of Pharmacy, Clinical Translational Sciences], Ph.D., Study director, University of Arizona, College of PharmacyAHMED A ALBERRY [Assistant prof of clinical pharmacology], Ph.D., Study director, Beni-Suef University, Faculty of medicineRAGHDA R SAYED [Lecturer of Clinical Pharmacy], Ph.D., Study director, Beni-Suef University, Faculty of PharmacyMOHAMED M ABDELWAHAB GAMALELDIN, Ph.D Student, Principal investigator, Beni-Suef University, Faculty of PharmacyMohamed H Meabad [Prof of Pediatrics], M.D, Study director, Beni-Suef university, Faculty of medicineAhmed F Mahmoud Hussein, MS.c, Study director, Beni-Suef Health insurance hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292314
- Sponsor's protocol ID
- TQ/Omega-3 on Thalassemia
- Status last verified
- Jan 2021
- First submitted
- 28 Feb 2020
- Last updated
- 27 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Combination Therapy Between Hydroxy Urea, Omega 3, Nigella Sativa and Honey on Antioxidant-oxidant Status and Reduction of Iron Overload in Pediatric Major Thalassemia
- ClinicalTrials.gov ID
- NCT04292314
- Acronym / sponsor ID
- TQ/Omega-3 on Thalassemia
- Conditions
- Iron Overload, Oxidative Stress, Thalassemia Major
- Keywords
- thymoquinone, omega3, hydroxyurea, pediatric Thalassemia Major, oxidative stress, iron chelation, iron overload, chelation activity of thymoquinone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- Maternity and Children Hospital, Makkah, Beni-Suef Health insurance hospital, University of Arizona
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Beta thalassemia is a blood disorder that reduces the production of hemoglobin. Hemoglobin is the iron-containing protein in red blood cells that carries oxygen to cells throughout the body. In people with beta thalassemia, low levels of hemoglobin lead to a lack of oxygen in many parts of the body. Affected individuals also have a shortage of red blood cells (anemia), which can cause pale skin, weakness, fatigue, and more serious complications. People with beta thalassemia are at an increased risk of developing abnormal blood clots. Beta thalassemia is classified into two types depending on the severity of symptoms: thalassemia major (also known as Cooley's anemia) and thalassemia intermedia. Of the two types, thalassemia major is more severe.
Beta-thalassemia syndromes are a group of hereditary blood disorders. It is characterized by reduced beta globin chain synthesis, resulting in reduced Hb in red blood cells (RBC), decreased RBC production and anemia.
Homozygotes for beta-thalassemia may develop either thalassemia major or thalassemia intermedia. Individuals with thalassemia major usually come to medical attention within the first 2 years and require regular blood transfusion to survive.
Affected infants with thalassemia major fail to thrive and become progressively pale. Feeding problems, diarrhea, irritability, recurrent bouts of fever, and enlargement of the abdomen, caused by splenomegaly, may occur. If a regular transfusion program that maintains a minimum Hb concentration of 95-105 g/L is initiated, then growth and development are normal until the age of 10-11 years. After the age of 10-11 years, affected individuals are at risk of developing severe complications related to posttransfusional iron overload, depending on their compliance with chelation therapy.
Complications of iron overload include growth retardation and failure of sexual maturation and also those complications observed in adults with hemachromatosis -associated hereditary hemochromatosis (HH): involvement of the heart (dilated myocardiopathy and pericarditis), liver (chronic hepatitis, fibrosis, and cirrhosis), and endocrine glands (resulting in diabetes mellitus and insufficiency of the parathyroid, thyroid, pituitary, and, less commonly, adrenal glands).
The underlying basis of b-thalassemia pathology is the diminished b-globin synthesis leading to a-globin accumulation and premature apoptotic destruction of erythroblasts, causing oxidative stress-induced ineffective erythropoiesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
- Model description
- Four experimental groups, one control group. Each experimental group receives different experimental treatments plus traditional treatment in the hospital and the control group receives only traditional treatment.
| Arm | Type | Receives |
|---|---|---|
| Omega-3 experimental group | Experimental | Drug: Omega 3, Drug: Deferoxamine, Procedure: blood transfusion session50 patients from each participating hospital that will receive Omega-3 supplementation (300-400mg EPA \& 200-300mg DHA) per day for 8 consecutive months up to 10 months. in addition to experimental treatment this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods till efficacy of experimental treatment proved. |
| Nigella sativa experimental group | Experimental | Drug: Nigella Sativa Oil, Drug: Deferoxamine, Procedure: blood transfusion session50 patients from each participating hospital that will receive Nigella sativa supplementation (1g black seed oil contain 1% thymoquinone) per day for 8 consecutive months up to 10 months. in addition to experimental treatment this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods till efficacy of experimental treatment proved. |
| Hydroxyurea experimental group | Experimental | Drug: Hydroxyurea, Drug: Deferoxamine, Procedure: blood transfusion session50 patients from each participating hospital that will receive hydroxyurea medication (5 to 15mg/kg) per day for 8 consecutive months up to 10 months. in addition to the experimental treatment, this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods until the efficacy of experimental treatment proved. |
| Natural honey experimental group | Experimental | Drug: Honey, Drug: Deferoxamine, Procedure: blood transfusion session50 patients from each participating hospital that will receive natural honey(2.5 mg/kg dissolved in 250 ml water) per day for 8 consecutive months up to 10 months. in addition to the experimental treatment, this group will receive the traditional treatment of deferoxamine/deferasirox plus regular blood transfusion with dose de-escalation methods until the efficacy of experimental treatment proved. |
| Ordinary hospital treatment group | Active comparator | Drug: Deferoxamine, Procedure: blood transfusion session50 patients from each participating hospital that will receive the ordinary treatment of iron chelator agent of deferoxamine or deferasirox (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. in addition to iron chelator agent, this group receive regular blood transfusion session. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Any case with full manifestation of β-THALASSEMIA major disease
- #Aged from 7-15 years old
- # accompanied with ineffective erythropoiesis
- # with low hemoglobin level
- # with iron overload
Key exclusion criteria (4 listed)
- The presence of any other chronic illness.
- Patient age>15 years old or < 7 years old.
- The presence of concomitant myocardial infarction, stroke, acute chest syndrome.
- The patient suffers from any other type of anemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega 3Omega-3 supplementation (300-400mg EPA \& 200-300mg DHA) per day for 8 consecutive months up to 10 months | Drug | Omega-3 experimental group |
| Nigella Sativa OilNigella sativa supplementation (1g black seed oil contain 1% thymoquinone) per day for 8 consecutive months up to 10 months | Drug | Nigella sativa experimental group |
| Hydroxyureahydroxyurea medication (5 to 15mg/kg) per day for 8 consecutive months up to 10 months. | Drug | Hydroxyurea experimental group |
| HoneyAlso: Natural honey formulationNatural honey(2.5 mg/kg dissolved in 250 ml water) per day for 8 consecutive months up to 10 months. | Drug | Natural honey experimental group |
| Deferoxaminedeferoxamine (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. | Drug | Hydroxyurea experimental group, Natural honey experimental group, Nigella sativa experimental group, Omega-3 experimental group, Ordinary hospital treatment group |
| blood transfusion sessionRegular blood transfusion session based on patient hematological profile starts from one session every 2 weeks. | Procedure or surgery | Hydroxyurea experimental group, Natural honey experimental group, Nigella sativa experimental group, Omega-3 experimental group, Ordinary hospital treatment group |
Primary outcome
F 2 -isoprostanes pg/mL
Time frame: 3 months
plasma F 2 -isoprostanes Picograms Per Millilitre measured by high pressure liquid chromatography assay
Total cholesterol Mg/dl
Time frame: 10 months
Total cholesterol milligrams per deciliter
HDL cholesterol Mg/dl
Time frame: 10 months
HDL cholesterol milligrams per deciliter
LDL cholesterol Mg/dl
Time frame: 10 months
LDL cholesterol milligrams per deciliter
Triglycerides Mg/dl
Time frame: 10 months
Triglycerides milligrams per deciliter
Serum total iron mcg/dL
Time frame: 10 months
Serum total iron micrograms per decilitre
% transferrin saturation
Time frame: 10 months
transferrin saturation percentage
C-reactive protein mg/L
Time frame: 10 months
C-reactive protein milligrams per deciliter
Serum Ferritin ng/ml
Time frame: 10 months
Serum Ferritin Nanograms per milliliter
Total Iron Binding Capacity (TIBC) mcg/dL
Time frame: 10 months
Total Iron Binding Capacity micrograms per decilitre
hemoglobin (Hbg) g/dL
Time frame: 10 months
hemoglobin (Hbg) gram/deciliter
mean corpuscular hemoglobin (MCH) pg/ml
Time frame: 10 months
mean corpuscular hemoglobin (MCH) Picograms Per Millilitre
leukocytes count μl
Time frame: 10 months
leukocytes in microliter
% Chelation activity Fe+++ - thymoquinone complex
Time frame: 3 months
Chelation activity of Ferric - thymoquinone complex in percentage measured by high pressure liquid chromatography coupled with gaschromatography - mass spectroscopy analysis
% Chelation activity Fe++ - thymoquinone complex
Time frame: 3 months
Chelation activity of Ferrous - thymoquinone complex in percentage measured by high pressure liquid chromatography coupled with gaschromatography- mass spectroscopy analysis
Lactic acid dehydrogenase U/L
Time frame: 10 months
Lactic acid dehydrogenase unit per litter
Reticulocyte count %
Time frame: 10 months
Reticulocyte count percentage
Hb-F level g/dL
Time frame: 10 months
hemoglobin- F level in gram per deciliter
Reticulocyte absolute count
Time frame: 10 months
Reticulocyte absolute count in a cubic milliliter of blood
White blood cells count
Time frame: 10 months
White blood cells count in a cubic milliliter of blood
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
IVO IBRAHAM [Prof of Pharmacy, Clinical Translational Sciences], Ph.D. study director
University of Arizona, College of Pharmacy
AHMED A ALBERRY [Assistant prof of clinical pharmacology], Ph.D. study director
Beni-Suef University, Faculty of medicine
RAGHDA R SAYED [Lecturer of Clinical Pharmacy], Ph.D. study director
Beni-Suef University, Faculty of Pharmacy
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Omega 3, Nigella Sativa Oil and Hydroxyurea in people with Iron Overload and Oxidative Stress, run by Beni-Suef University at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Egypt, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
F 2 -isoprostanes pg/mL (time frame: 3 months). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.