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NCT Number: NCT04292314

Hydroxy Urea, Omega 3, Nigella Sativa,Honey on Oxidative Stress and Iron Chelation 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.

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Key information

Conditions

Iron Overload Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Oxidative Stress Thalassemia Thalassemia Major beta-Thalassemia

Age range

7 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faculty of Pharmacy, Beni-Suef university, Banī Suwayf, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

OMega 3

Drug

Omega-3 supplementation (300-400mg EPA & 200-300mg DHA) per day for 8 consecutive months up to 10 months

Nigella Sativa Oil

Drug

Nigella sativa supplementation (1g black seed oil contain 1% thymoquinone) per day for 8 consecutive months up to 10 months

Hydroxyurea

Drug

hydroxyurea medication (5 to 15mg/kg) per day for 8 consecutive months up to 10 months.

Honey

Drug

Natural honey(2.5 mg/kg dissolved in 250 ml water) per day for 8 consecutive months up to 10 months.

Other names: Natural honey formulation

Deferoxamine

Drug

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 session

Procedure

Regular blood transfusion session based on patient hematological profile starts from one session every 2 weeks.

Primary outcomes

  1. F 2 -isoprostanes pg/mL

    Time frame: 3 months

    plasma F 2 -isoprostanes Picograms Per Millilitre measured by high pressure liquid chromatography assay

  2. Total cholesterol Mg/dl

    Time frame: 10 months

    Total cholesterol milligrams per deciliter

  3. HDL cholesterol Mg/dl

    Time frame: 10 months

    HDL cholesterol milligrams per deciliter

  4. LDL cholesterol Mg/dl

    Time frame: 10 months

    LDL cholesterol milligrams per deciliter

  5. Triglycerides Mg/dl

    Time frame: 10 months

    Triglycerides milligrams per deciliter

  6. Serum total iron mcg/dL

    Time frame: 10 months

    Serum total iron micrograms per decilitre

  7. % transferrin saturation

    Time frame: 10 months

    transferrin saturation percentage

  8. C-reactive protein mg/L

    Time frame: 10 months

    C-reactive protein milligrams per deciliter

  9. Serum Ferritin ng/ml

    Time frame: 10 months

    Serum Ferritin Nanograms per milliliter

  10. Total Iron Binding Capacity (TIBC) mcg/dL

    Time frame: 10 months

    Total Iron Binding Capacity micrograms per decilitre

  11. hemoglobin (Hbg) g/dL

    Time frame: 10 months

    hemoglobin (Hbg) gram/deciliter

  12. mean corpuscular hemoglobin (MCH) pg/ml

    Time frame: 10 months

    mean corpuscular hemoglobin (MCH) Picograms Per Millilitre

  13. leukocytes count μl

    Time frame: 10 months

    leukocytes in microliter

  14. % 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

  15. % 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

  16. Lactic acid dehydrogenase U/L

    Time frame: 10 months

    Lactic acid dehydrogenase unit per litter

  17. Reticulocyte count %

    Time frame: 10 months

    Reticulocyte count percentage

  18. Hb-F level g/dL

    Time frame: 10 months

    hemoglobin- F level in gram per deciliter

  19. Reticulocyte absolute count

    Time frame: 10 months

    Reticulocyte absolute count in a cubic milliliter of blood

  20. White blood cells count

    Time frame: 10 months

    White blood cells count in a cubic milliliter of blood

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Collaborators

  • Beni-Suef Health insurance hospital
  • Maternity and Children Hospital, Makkah
  • University of Arizona

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 3, 2020
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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