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

Sponsor
Al-Neelain University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04191213
Collaborator
University of Khartoum (Other)
100
Enrollment
1
Location
2
Arms
5
Anticipated Duration (Months)
20.2
Patients Per Site Per Month

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Anticipated 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 pectinThe 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
Anticipated Study Start Date :
Feb 15, 2020
Anticipated Primary Completion Date :
Jun 15, 2020
Anticipated Study Completion Date :
Jul 15, 2020

Arms and Interventions

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 Names:
  • (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

    Primary Outcome Measures

    1. Fetal hemoglobin level after 12 weeks [12 weeks]

      Measure increase from the baseline values

    2. Total anti oxidant capacity [12 weeks]

      Measure increase from the baseline values

    Secondary Outcome Measures

    1. Anti inflammatory marker C reactive Protein [12 weeks]

      Measure decrease from the baseline values

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Military Hospital Omdurman Khartoum Sudan 1113

    Sponsors and Collaborators

    • Al-Neelain University
    • University of Khartoum

    Investigators

    • Study Director: Imad M Fdl-Elmula, PhD, Alneelain University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Lamis Kaddam, Director, Al-Neelain University
    ClinicalTrials.gov Identifier:
    NCT04191213
    Other Study ID Numbers:
    • GA& Sickle among children
    First Posted:
    Dec 9, 2019
    Last Update Posted:
    Jan 28, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lamis Kaddam, Director, Al-Neelain University
    sickle cell anemia
    Gum Arabic
    Fetal Hemoglobin
    Additional relevant MeSH terms:
    Anemia
    Anemia, Sickle Cell

    Study Results

    No Results Posted as of Jan 28, 2020