Gum Arabic as Anti-oxidant, Anti-inflammatory and Fetal Hemoglobin Inducing Agent in Sickle Cell Anemia Patients

Study Overview
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Brief Summary
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To study the efficacy of Gum Arabic as an anti-oxidant, anti-inflammatory and Fetal Hemoglobin-inducing agent among Sickle Cell Disease children. Half of participants will receive Gum Arabic and the other half will receive placebo

Detailed Description
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Polymerized hemoglobin is injurious to the red cell membrane, resulting in oxidative damage in sickle cell disease . Fetal hemoglobin is protective against sickling and its decrease is associated with vaso-occlusive crisis . Gum Arabic is soluble fibers with prebiotic properties. It increased the level of serum butyrate which is short chain fatty acid. The latter proved to serve as fetal hemoglobin inducing agent both in vivo and in vitro study. And also has strong anti-inflammatory properties. So our aim to test whether oral digestion of Gum Arabic will induce fetal hemoglobin among sickle cell pediatric patients

Official Title
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Efficacy of Gum Arabic as Anti-oxidant, Anti-inflammatory and Fetal Hemoglobin Inducing Agent in Sickle Cell Anemia Patients : A Randomized, Double-blind, Two-armed Parallel-group, Placebo-controlled Phase II/III Study - Khartoum, Sudan

Conditions
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Sickle Cell Anemia in Children

Intervention / Treatment
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* Dietary Supplement: Acacia Senegal extract
* Dietary Supplement: Pectin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Homozygous for Sickle Cell Disease (SS) as documented by Haemoglobin electrophoresis. Subjects whom medications and dosages had been stable for 2 weeks before study entry. Subjects who have not received blood transfusion or had acute episode related to sickle cell disease in the last two weeks before the start of intervention. Exclusion Criteria: Patients with history of Gum Arabic allergy. Patients who have ischemic heart disease, liver dysfunction or hepatitis. Pregnant female patients who plan to conceive in the next 4 months and fertile female patients who are not using an effective contraception method. Patients who are currently using Gum Arabic. Patients who are on steroids or chemotherapy.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The intervention group will receive Gum Arabic. And The placebo group will receive pectin
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>This arm will receive 100% natural Gum Arabic provided in a powder form in 30-grams-dose for participants above 5 years of age and 15-grams-dose for participants below 5 years of age for 12 weeks | Dietary Supplement: Acacia Senegal extract<br>* Oral Digestion of Gum Arabic to be consumed early morning in daily basis for 12 weeks<br>* Other names: (Gum Arabic);|
| Placebo Comparator: Control group<br>This group will be provided with pectin powder provided as one-gram-dose for children below 5 years of age & two-gram-dose for children above 5 years of age | Dietary Supplement: Pectin<br>* Oral Digestion of Pectin to be consumed early morning in daily basis for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal hemoglobin level after 12 weeks | Measure increase from the baseline values | 12 weeks | 
| Total anti oxidant capacity | Measure increase from the baseline values | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti inflammatory marker C reactive Protein | Measure decrease from the baseline values | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sickle cell anemia, Gum Arabic, Fetal Hemoglobin