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

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04191213

Acronym

GA&SCA

Enrollment

100

Registered

2019-12-09

Start date

2020-02-15

Completion date

2020-07-15

Last updated

2020-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Anemia in Children

Keywords

sickle cell anemia, Gum Arabic, Fetal Hemoglobin

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

Interventions

DIETARY_SUPPLEMENTAcacia Senegal extract

Oral Digestion of Gum Arabic to be consumed early morning in daily basis for 12 weeks

DIETARY_SUPPLEMENTPectin

Oral Digestion of Pectin to be consumed early morning in daily basis for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Participants, care providers, Investigator and outcome assessor will be masked regarding the type of intervention each group will receive

Intervention model description

The intervention group will receive Gum Arabic. And The placebo group will receive pectin

Eligibility

Sex/Gender

ALL

Age

3 Years to 18 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Anti inflammatory marker C reactive Protein	12 weeks	Measure decrease from the baseline values

Countries

Sudan

Contacts

Primary ContactDalya MM Abdelmaged, MBBS

dalya.alfeel@gmail.com00249126831595

Backup ContactLamis AA KAddam, PhD

lamiskaddam@hotmail.com+249912979736

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026