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

Phase 2

• Conditions: Sickle Cell Anemia in Children
• Interventions: Dietary Supplement: Acacia Senegal extract; Dietary Supplement: Pectin

• Registration Number: NCT04191213
• Lead Sponsor: Al-Neelain University

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

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 Timeline

• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-06
• Study First Posted: 2019-12-09
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-26
• Last Update Posted: 2020-01-28
• Study Start: 2020-02-15
• Primary Completion: 2020-06-15
• Study Completion: 2020-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Acacia Senegal extract	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
Control group	Pectin	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

Primary Outcome Measures

Name	Time	Method
Total anti oxidant capacity	12 weeks	Measure increase from the baseline values
Fetal hemoglobin level after 12 weeks	12 weeks	Measure increase from the baseline values

Secondary Outcome Measures

Name	Time	Method
Anti inflammatory marker C reactive Protein	12 weeks	Measure decrease from the baseline values

Trial Locations

Locations (1)

Military Hospital; 🇸🇩 Omdurman, Khartoum, Sudan