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

Last updated: January 26, 2020
Sponsor: Al-Neelain University
Overall Status: Active - Recruiting

Phase

2/3

Condition

Anemia

Treatment

N/A

Clinical Study ID

NCT04191213
GA& Sickle among children
  • Ages 3-18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 sicklecell disease in the last two weeks before the start of intervention.

Exclusion

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 thenext 4 months and fertile female patients who are not using an effective contraceptionmethod. Patients who are currently using Gum Arabic. Patients who are on steroids or chemotherapy.

Study Design

Total Participants: 100
Study Start date:
February 15, 2020
Estimated Completion Date:
July 15, 2020

Study 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

Connect with a study center

  • Military Hospital

    Omdurman, Khartoum 1113
    Sudan

    Active - Recruiting

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