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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 4
- 主要终点
- Reticulocyte absolute count
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Omega-3 experimental group
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.
干预措施: Omega 3 (Drug)
Omega-3 experimental group
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.
干预措施: Deferoxamine (Drug)
Omega-3 experimental group
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.
干预措施: blood transfusion session (Procedure)
Nigella sativa experimental group
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.
干预措施: Nigella Sativa Oil (Drug)
Nigella sativa experimental group
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.
干预措施: Deferoxamine (Drug)
Nigella sativa experimental group
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.
干预措施: blood transfusion session (Procedure)
Hydroxyurea experimental group
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.
干预措施: Hydroxyurea (Drug)
Hydroxyurea experimental group
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.
干预措施: Deferoxamine (Drug)
Hydroxyurea experimental group
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.
干预措施: blood transfusion session (Procedure)
Natural honey experimental group
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.
干预措施: Honey (Drug)
Natural honey experimental group
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.
干预措施: Deferoxamine (Drug)
Natural honey experimental group
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.
干预措施: blood transfusion session (Procedure)
Ordinary hospital treatment group
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.
干预措施: Deferoxamine (Drug)
Ordinary hospital treatment group
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.
干预措施: blood transfusion session (Procedure)
结局指标
主要结局
Reticulocyte absolute count
时间窗: 10 months
Reticulocyte absolute count in a cubic milliliter of blood
HDL cholesterol Mg/dl
时间窗: 10 months
HDL cholesterol milligrams per deciliter
LDL cholesterol Mg/dl
时间窗: 10 months
LDL cholesterol milligrams per deciliter
C-reactive protein mg/L
时间窗: 10 months
C-reactive protein milligrams per deciliter
Serum Ferritin ng/ml
时间窗: 10 months
Serum Ferritin Nanograms per milliliter
leukocytes count μl
时间窗: 10 months
leukocytes in microliter
Total Iron Binding Capacity (TIBC) mcg/dL
时间窗: 10 months
Total Iron Binding Capacity micrograms per decilitre
hemoglobin (Hbg) g/dL
时间窗: 10 months
hemoglobin (Hbg) gram/deciliter
% Chelation activity Fe+++ - thymoquinone complex
时间窗: 3 months
Chelation activity of Ferric - thymoquinone complex in percentage measured by high pressure liquid chromatography coupled with gaschromatography - mass spectroscopy analysis
mean corpuscular hemoglobin (MCH) pg/ml
时间窗: 10 months
mean corpuscular hemoglobin (MCH) Picograms Per Millilitre
% transferrin saturation
时间窗: 10 months
transferrin saturation percentage
Serum total iron mcg/dL
时间窗: 10 months
Serum total iron micrograms per decilitre
F 2 -isoprostanes pg/mL
时间窗: 3 months
plasma F 2 -isoprostanes Picograms Per Millilitre measured by high pressure liquid chromatography assay
Total cholesterol Mg/dl
时间窗: 10 months
Total cholesterol milligrams per deciliter
% Chelation activity Fe++ - thymoquinone complex
时间窗: 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
时间窗: 10 months
Lactic acid dehydrogenase unit per litter
Reticulocyte count %
时间窗: 10 months
Reticulocyte count percentage
Hb-F level g/dL
时间窗: 10 months
hemoglobin- F level in gram per deciliter
Triglycerides Mg/dl
时间窗: 10 months
Triglycerides milligrams per deciliter
White blood cells count
时间窗: 10 months
White blood cells count in a cubic milliliter of blood
次要结局
未报告次要终点
研究者
Mohamed Medhat Abdelwahab Gamaleldin
Dr.Mohamed Medhat Abdelwahab Gamaleldin
Beni-Suef University