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

NCT04191213 | Unknown Phase 2 DMC

• 1 other identifier: GA& Sickle among children
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Sickle Cell Anemia in Children

Keywords

sickle cell anemia; Gum Arabic; Fetal Hemoglobin

Outcome Measures

Primary Outcomes (2)

• Fetal hemoglobin level after 12 weeks

  Measure increase from the baseline values

  12 weeks

• Total anti oxidant capacity

  Measure increase from the baseline values

  12 weeks

Secondary Outcomes (1)

• Anti inflammatory marker C reactive Protein

  12 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

Acacia Senegal extract DIETARY_SUPPLEMENT

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

Also known as: (Gum Arabic)

Intervention Group

Pectin DIETARY_SUPPLEMENT

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

Control group

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Neelain University: lead
• University of Khartoum: collaborator

Study Sites (1)

Military Hospital

Omdurman, Khartoum State, 1113, Sudan

RECRUITING

Related Publications (3)

• 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.

  PMID: 26719803 BACKGROUND

• 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.

  PMID: 28331623 BACKGROUND

• 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.

  PMID: 30112005 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell; beta-Thalassemia

Interventions

Gum Arabic; Pectins

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Thalassemia

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Plant Extracts; Plant Preparations

Study Officials

• Imad M Fdl-Elmula, PhD

  Alneelain University

  STUDY DIRECTOR

Central Study Contacts

Dalya MM Abdelmaged, MBBS

CONTACT

00249126831595; dalya.alfeel@gmail.com

Lamis AA KAddam, PhD

CONTACT

+249912979736; lamiskaddam@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, Investigator and outcome assessor will be masked regarding the type of intervention each group will receive
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: The intervention group will receive Gum Arabic. And The placebo group will receive pectin

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 9, 2019
• Study Start: February 15, 2020
• Primary Completion: June 15, 2020
• Study Completion: July 15, 2020
• Last Updated: January 28, 2020

Record last verified: 2020-01

Locations

SU (1)