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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04292314
Other study ID # TQ/Omega-3 on Thalassemia
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date November 1, 2019
Est. completion date January 20, 2021

Study information

Verified date January 2021
Source Beni-Suef University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 major thalassemia.


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.


Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date January 20, 2021
Est. primary completion date December 20, 2020
Accepts healthy volunteers No
Gender All
Age group 7 Years to 15 Years
Eligibility Inclusion Criteria: 1. Any case with full manifestation of ß-THALASSEMIA major disease 2. #Aged from 7-15 years old 3. # accompanied with ineffective erythropoiesis 4. # with low hemoglobin level 5. # with iron overload Exclusion Criteria: 1. The presence of any other chronic illness. 2. Patient age>15 years old or < 7 years old. 3. The presence of concomitant myocardial infarction, stroke, acute chest syndrome. 4. The patient suffers from any other type of anemia.

Study Design


Intervention

Drug:
Omega 3
Omega-3 supplementation (300-400mg EPA & 200-300mg DHA) per day for 8 consecutive months up to 10 months
Nigella Sativa Oil
Nigella sativa supplementation (1g black seed oil contain 1% thymoquinone) per day for 8 consecutive months up to 10 months
Hydroxyurea
hydroxyurea medication (5 to 15mg/kg) per day for 8 consecutive months up to 10 months.
Honey
Natural honey(2.5 mg/kg dissolved in 250 ml water) per day for 8 consecutive months up to 10 months.
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.

Locations

Country Name City State
Egypt Faculty of medicine, Beni-suef univeristy - Beni-Suef university hospital Bani Suwayf
Egypt Faculty of Pharmacy, Beni-Suef university Bani Suwayf
Egypt Health insurance hospital Bani Suwayf
Saudi Arabia Maternity and Children hospital Mecca

Sponsors (6)

Lead Sponsor Collaborator
Beni-Suef University Beni-Suef Health insurance hospital, College of Pharmacy,Department of Pharmacy Practice,University of Arizona, Department of clinical pharmacy, faculty of pharmacy, Beni-suef univeristy, Maternity and Children Hospital, Makkah, University of Arizona

Countries where clinical trial is conducted

Egypt,  Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary F 2 -isoprostanes pg/mL plasma F 2 -isoprostanes Picograms Per Millilitre measured by high pressure liquid chromatography assay 3 months
Primary Total cholesterol Mg/dl Total cholesterol milligrams per deciliter 10 months
Primary HDL cholesterol Mg/dl HDL cholesterol milligrams per deciliter 10 months
Primary LDL cholesterol Mg/dl LDL cholesterol milligrams per deciliter 10 months
Primary Triglycerides Mg/dl Triglycerides milligrams per deciliter 10 months
Primary Serum total iron mcg/dL Serum total iron micrograms per decilitre 10 months
Primary % transferrin saturation transferrin saturation percentage 10 months
Primary C-reactive protein mg/L C-reactive protein milligrams per deciliter 10 months
Primary Serum Ferritin ng/ml Serum Ferritin Nanograms per milliliter 10 months
Primary Total Iron Binding Capacity (TIBC) mcg/dL Total Iron Binding Capacity micrograms per decilitre 10 months
Primary hemoglobin (Hbg) g/dL hemoglobin (Hbg) gram/deciliter 10 months
Primary mean corpuscular hemoglobin (MCH) pg/ml mean corpuscular hemoglobin (MCH) Picograms Per Millilitre 10 months
Primary leukocytes count µl leukocytes in microliter 10 months
Primary % 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 3 months
Primary % 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 3 months
Primary Lactic acid dehydrogenase U/L Lactic acid dehydrogenase unit per litter 10 months
Primary Reticulocyte count % Reticulocyte count percentage 10 months
Primary Hb-F level g/dL hemoglobin- F level in gram per deciliter 10 months
Primary Reticulocyte absolute count Reticulocyte absolute count in a cubic milliliter of blood 10 months
Primary White blood cells count White blood cells count in a cubic milliliter of blood 10 months
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