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Gum Arabic as Anti-oxidant, Anti-inflammatory and Fetal Hemoglobin Inducing Agent in Sickle Cell Anemia Patients (GA&SCA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04191213
Recruitment Status : Unknown
Verified January 2020 by Lamis Kaddam, Al-Neelain University.
Recruitment status was:  Recruiting
First Posted : December 9, 2019
Last Update Posted : January 28, 2020
Sponsor:
Collaborator:
University of Khartoum
Information provided by (Responsible Party):
Lamis Kaddam, Al-Neelain University

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Sickle Cell Anemia in Children Dietary Supplement: Acacia Senegal extract Dietary Supplement: Pectin Phase 2 Phase 3

Detailed Description:
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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The intervention group will receive Gum Arabic. And The placebo group will receive pectin
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants, care providers, Investigator and outcome assessor will be masked regarding the type of intervention each group will receive
Primary Purpose: Supportive Care
Official Title: 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
Estimated Study Start Date : February 15, 2020
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Antioxidants
Drug Information available for: Pectin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Group
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
Oral Digestion of Gum Arabic to be consumed early morning in daily basis for 12 weeks
Other Name: (Gum Arabic)
Placebo Comparator: Control group
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
Oral Digestion of Pectin to be consumed early morning in daily basis for 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Fetal hemoglobin level after 12 weeks [ Time Frame: 12 weeks ]
    Measure increase from the baseline values

  2. Total anti oxidant capacity [ Time Frame: 12 weeks ]
    Measure increase from the baseline values


Secondary Outcome Measures :
  1. Anti inflammatory marker C reactive Protein [ Time Frame: 12 weeks ]
    Measure decrease from the baseline values


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04191213


Contacts
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Contact: Dalya MM Abdelmaged, MBBS 00249126831595 dalya.alfeel@gmail.com
Contact: Lamis AA KAddam, PhD +249912979736 lamiskaddam@hotmail.com

Locations
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Sudan
Military Hospital Recruiting
Omdurman, Khartoum, Sudan, 1113
Contact: Haydar A Abdelrazig, MD    249123431031    habdelhakam1@hotmail.com   
Sub-Investigator: Haydar A Abdelrazig, MD         
Principal Investigator: Dalya MM Abdelmaged, MBBS         
Sub-Investigator: Lamis AA Kaddam, PhD         
Sponsors and Collaborators
Al-Neelain University
University of Khartoum
Investigators
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Study Director: Imad M Fdl-Elmula, PhD Alneelain University
More Information
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Publications:

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Responsible Party: Lamis Kaddam, Director, Al-Neelain University
ClinicalTrials.gov Identifier: NCT04191213    
Other Study ID Numbers: GA& Sickle among children
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Share patients data without personal data and without breaching confidentiality

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lamis Kaddam, Al-Neelain University:
sickle cell anemia
Gum Arabic
Fetal Hemoglobin
Additional relevant MeSH terms:
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Anemia
Anemia, Sickle Cell
Hematologic Diseases
Anemia, Hemolytic, Congenital
 Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn