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

January 26, 2020 updated by: Lamis Kaddam, Al-Neelain University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sudan
    • Khartoum
      • Omdurman, Khartoum, Sudan, 1113
        • Recruiting
        • Military Hospital
        • Contact:
        • Sub-Investigator:
          • Haydar A Abdelrazig, MD
        • Principal Investigator:
          • Dalya MM Abdelmaged, MBBS
        • Sub-Investigator:
          • Lamis AA Kaddam, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Dietary supplement: Acacia Senegal extract
Oral Digestion of Gum Arabic to be consumed early morning in daily basis for 12 weeks
Other Names:
  • (Gum Arabic)
Placebo Comparator: 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
Dietary supplement: Pectin
Oral Digestion of Pectin to be consumed early morning in daily basis for 12 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Neelain University

Collaborators

University of Khartoum

Investigators

  • Study Director: Imad M Fdl-Elmula, PhD, Alneelain University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 15, 2020

Primary Completion (Anticipated)

June 15, 2020

Study Completion (Anticipated)

July 15, 2020

Study Registration Dates

First Submitted

December 5, 2019

First Submitted That Met QC Criteria

December 6, 2019

First Posted (Actual)

December 9, 2019

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 26, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA& Sickle among children

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Share patients data without personal data and without breaching confidentiality

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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