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

Primary Purpose

Sickle Cell Anemia in Children

Status

Unknown status

Phase

Phase 2

Locations

Sudan

Study Type

Interventional

Intervention

Acacia Senegal extract

Pectin

About this trial

This is an interventional supportive care trial for Sickle Cell Anemia in Children focused on measuring sickle cell anemia, Gum Arabic, Fetal Hemoglobin

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

Military HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention Group

Control group

Arm 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

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

Outcomes

Primary Outcome Measures

Fetal hemoglobin level after 12 weeks

Measure increase from the baseline values

Total anti oxidant capacity

Measure increase from the baseline values

Secondary Outcome Measures

Anti inflammatory marker C reactive Protein

Measure decrease from the baseline values

Full Information

NCT ID

NCT04191213

First Posted

December 5, 2019

Last Updated

January 26, 2020

Sponsor

Al-Neelain University

Collaborators

University of Khartoum

1. Study Identification

Unique Protocol Identification Number

NCT04191213

Brief Title

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

Acronym

GA&SCA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

February 15, 2020 (Anticipated)

Primary Completion Date

June 15, 2020 (Anticipated)

Study Completion Date

July 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Al-Neelain University

Collaborators

University of Khartoum

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sickle Cell Anemia in Children

Keywords

sickle cell anemia, Gum Arabic, Fetal Hemoglobin

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm 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

Arm Title

Control group

Arm Type

Placebo Comparator

Arm 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

Intervention Type

Dietary Supplement

Intervention Name(s)

Acacia Senegal extract

Other Intervention Name(s)

(Gum Arabic)

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Pectin

Intervention Description

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

Primary Outcome Measure Information:

Title

Fetal hemoglobin level after 12 weeks

Description

Measure increase from the baseline values

Time Frame

12 weeks

Title

Total anti oxidant capacity

Description

Measure increase from the baseline values

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Anti inflammatory marker C reactive Protein

Description

Measure decrease from the baseline values

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dalya MM Abdelmaged, MBBS

Phone

00249126831595

dalya.alfeel@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Lamis AA KAddam, PhD

Phone

+249912979736

lamiskaddam@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Imad M Fdl-Elmula, PhD

Organizational Affiliation

Alneelain University

Official's Role

Study Director

Facility Information:

Facility Name

Military Hospital

City

Omdurman

State/Province

Khartoum

ZIP/Postal Code

1113

Country

Sudan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Haydar A Abdelrazig, MD

Phone

249123431031

habdelhakam1@hotmail.com

First Name & Middle Initial & Last Name & Degree

Haydar A Abdelrazig, MD

First Name & Middle Initial & Last Name & Degree

Dalya MM Abdelmaged, MBBS

First Name & Middle Initial & Last Name & Degree

Lamis AA Kaddam, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Share patients data without personal data and without breaching confidentiality

Citations:

PubMed Identifier

26719803

Citation

Kaddam L, FdleAlmula I, Eisawi OA, Abdelrazig HA, Elnimeiri M, Lang F, Saeed AM. Gum Arabic as fetal hemoglobin inducing agent in sickle cell anemia; in vivo study. BMC Hematol. 2015 Dec 29;15:19. doi: 10.1186/s12878-015-0040-6. eCollection 2015.

Results Reference

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PubMed Identifier

28331623

Citation

Kaddam L, Fadl-Elmula I, Eisawi OA, Abdelrazig HA, Salih MA, Lang F, Saeed AM. Gum Arabic as novel anti-oxidant agent in sickle cell anemia, phase II trial. BMC Hematol. 2017 Mar 16;17:4. doi: 10.1186/s12878-017-0075-y. eCollection 2017.

Results Reference

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PubMed Identifier

30112005

Citation

Kamal E, Kaddam LA, Dahawi M, Osman M, Salih MA, Alagib A, Saeed A. Gum Arabic Fibers Decreased Inflammatory Markers and Disease Severity Score among Rheumatoid Arthritis Patients, Phase II Trial. Int J Rheumatol. 2018 Jul 5;2018:4197537. doi: 10.1155/2018/4197537. eCollection 2018.

Results Reference

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

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