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

Sickle Cell Anemia in Children Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04191213
• Other study ID #: GA& Sickle among children
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: February 15, 2020
• Est. completion date: July 15, 2020

Study information

• Verified date: January 2020
• Source: Al-Neelain University
• Contact: Dalya MM Abdelmaged, MBBS
• Phone: 00249126831595
• Email: dalya.alfeel[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 15, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Sickle Cell
• 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
• Pectin
Oral Digestion of Pectin to be consumed early morning in daily basis for 12 weeks

Locations

Country	Name	City	State
Sudan	Military Hospital	Omdurman	Khartoum

Sponsors (2)

Lead Sponsor	Collaborator
Al-Neelain University	University of Khartoum

Country where clinical trial is conducted

Sudan, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal hemoglobin level after 12 weeks	Measure increase from the baseline values	12 weeks
Primary	Total anti oxidant capacity	Measure increase from the baseline values	12 weeks
Secondary	Anti inflammatory marker C reactive Protein	Measure decrease from the baseline values	12 weeks