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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-15

Study Completion Date

2020-07-15

Brief Summary

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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

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Detailed Description

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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

Conditions

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Sickle Cell Anemia in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Study Groups

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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

Group Type EXPERIMENTAL

Acacia Senegal extract

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type PLACEBO_COMPARATOR

Pectin

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Acacia Senegal extract

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

Intervention Type DIETARY_SUPPLEMENT

Pectin

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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(Gum Arabic)

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No