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

A

Al-Neelain University

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Sickle Cell Anemia in Children

Treatments

Dietary Supplement: Acacia Senegal extract
Dietary Supplement: Pectin

Study type

Interventional

Funder types

Other

Identifiers

NCT04191213
GA& Sickle among children

Details and patient eligibility

About

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

Full 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

Enrollment

100 estimated patients

Sex

All

Ages

3 to 18 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups, including a placebo group

Intervention Group
Experimental group
Description:
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
Treatment:
Dietary Supplement: Acacia Senegal extract
Control group
Placebo Comparator group
Description:
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
Treatment:
Dietary Supplement: Pectin

Trial contacts and locations

0

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Central trial contact

Dalya MM Abdelmaged, MBBS; Lamis AA KAddam, PhD

Data sourced from clinicaltrials.gov

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