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

• ClinicalTrials.gov Identifier: NCT04191213
• Recruitment Status: Unknown
• First Posted: December 9, 2019
• Last Update Posted: January 28, 2020
• Sponsor: Al-Neelain University
• Collaborator: University of Khartoum
• Information provided by (Responsible Party): Lamis Kaddam, Al-Neelain University

Tracking Information

• First Submitted Date: December 5, 2019
• First Posted Date: December 9, 2019
• Last Update Posted Date: January 28, 2020
• Estimated Study Start Date: February 15, 2020
• Estimated Primary Completion Date: June 15, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 6, 2019)

• Fetal hemoglobin level after 12 weeks [ Time Frame: 12 weeks ]
  Measure increase from the baseline values
• Total anti oxidant capacity [ Time Frame: 12 weeks ]
  Measure increase from the baseline values

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 26, 2020)

Anti inflammatory marker C reactive Protein [ Time Frame: 12 weeks ]

Measure decrease from the baseline values

Original Secondary Outcome Measures (submitted: December 6, 2019)

Anti inflammatory marker C reactive Protein [ Time Frame: 12 weeks ]

Measure increase from the baseline values

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Gum Arabic as Anti-oxidant, Anti-inflammatory and Fetal Hemoglobin Inducing Agent in Sickle Cell Anemia Patients
• 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
• 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
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

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

Primary Purpose: Supportive Care

• Condition: Sickle Cell Anemia in Children

Intervention

• Dietary Supplement: Acacia Senegal extract
  Oral Digestion of Gum Arabic to be consumed early morning in daily basis for 12 weeks
  Other Name: (Gum Arabic)
• Dietary Supplement: Pectin
  Oral Digestion of Pectin to be consumed early morning in daily basis for 12 weeks

Study Arms

• 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
  Intervention: Dietary Supplement: Acacia Senegal extract
• 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
  Intervention: Dietary Supplement: Pectin

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 6, 2019): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 15, 2020
• Estimated Primary Completion Date: June 15, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 3 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sudan

Administrative Information

• NCT Number: NCT04191213
• Other Study ID Numbers: GA& Sickle among children
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: Share patients data without personal data and without breaching confidentiality

• Current Responsible Party: Lamis Kaddam, Al-Neelain University
• Original Responsible Party: Lamis Kaddam, Al-Neelain University, Dr
• Current Study Sponsor: Al-Neelain University
• Original Study Sponsor: Same as current
• Collaborators: University of Khartoum

Investigators

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

• PRS Account: Al-Neelain University
• Verification Date: January 2020