Gum Arabic as Fetal Hemoglobin Agent in Sickle Cell Anemia

• ClinicalTrials.gov Identifier: NCT02467257
• Recruitment Status: Completed
• First Posted: June 10, 2015
• Last Update Posted: June 10, 2015
• Sponsor: Al-Neelain University
• Collaborators: Military hospital; Ministry of Higher Education and Scientific Research, Republic of Sudan
• Information provided by (Responsible Party): Lamis Kaddam, Al-Neelain University

Tracking Information

• First Submitted Date: June 4, 2015
• First Posted Date: June 10, 2015
• Last Update Posted Date: June 10, 2015
• Study Start Date: April 2014
• Actual Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 5, 2015)

The primary endpoint of the study will be the level of fetal hemoglobin after three months [ Time Frame: 12 weeks ]

fetal hemoglobin will be measured each month for three months

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Gum Arabic as Fetal Hemoglobin Agent in Sickle Cell Anemia
• Official Title: Potential Role of Gum Arabic as Fetal Hemoglobin Agent in Sudanese Sickle Cell Anemia Patients
• Brief Summary: The purpose of this study is to determine whether Gum Arabic is effective as fetal hemoglobin inducing agent for sickle cell anemia patients.
• Detailed Description: : High level of fetal haemoglobin (Hb F) decreases sickle cell anaemia (SCA) severity and leads to improved survival. Butyrate proved to increase HbF production in vivo and in vitro studies. Nonetheless, its short half-life limited its utilization in clinical practice. Gum Arabic (GA) is edible, dried, gummy exudate from Acacia Senegal tree. GA fermentation by colonic bacteria increases serum butyrate concentrations. The investigators hypothesized regular intake of GA will increase serum butyrate level. The latter will induce fetal hemoglobin production and ameliorate patients' symptoms. 47 patients hemoglobin SS aged 5-42 years, on regular follow up in Military hospital were recruited from April 2014 to January 2015 Patients received dose of G A 30g/day for 12 weeks. Hb F, complete blood count and Erythropoietin level were measured. The main outcome of interest was the level of HbF after 12 weeks.
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Sickle Cell Anemia

Intervention

Dietary Supplement: Gum Arabic

oral ingestion of 30 gram every day for 12 weeks

Study Arms

Experimental: Intrevention arm

Patients received Gum Arabic as intervention

Intervention: Dietary Supplement: Gum Arabic

Publications *

• Fathallah H, Atweh GF. Induction of fetal hemoglobin in the treatment of sickle cell disease. Hematology Am Soc Hematol Educ Program. 2006:58-62. doi: 10.1182/asheducation-2006.1.58.
• Kutlar A, Reid ME, Inati A, Taher AT, Abboud MR, El-Beshlawy A, Buchanan GR, Smith H, Ataga KI, Perrine SP, Ghalie RG. A dose-escalation phase IIa study of 2,2-dimethylbutyrate (HQK-1001), an oral fetal globin inducer, in sickle cell disease. Am J Hematol. 2013 Nov;88(11):E255-60. doi: 10.1002/ajh.23533. Epub 2013 Oct 3.
• Matsumoto N, Riley S, Fraser D, Al-Assaf S, Ishimura E, Wolever T, Phillips GO, Phillips AO. Butyrate modulates TGF-beta1 generation and function: potential renal benefit for Acacia(sen) SUPERGUM (gum arabic)? Kidney Int. 2006 Jan;69(2):257-65. doi: 10.1038/sj.ki.5000028.
• Ballal A, Bobbala D, Qadri SM, Foller M, Kempe D, Nasir O, Saeed A, Lang F. Anti-malarial effect of gum arabic. Malar J. 2011 May 20;10:139. doi: 10.1186/1475-2875-10-139.
• Kaddam LA, Kaddam AS. Effect of Gum Arabic (Acacia senegal) on C-reactive protein level among sickle cell anemia patients. BMC Res Notes. 2020 Mar 18;13(1):162. doi: 10.1186/s13104-020-05016-2.
• Kaddam L, Fadl-Elmula I, Eisawi OA, Abdelrazig HA, Saeed AM. Acacia Senegal (Gum Arabic) Supplementation Modulate Lipid Profile and Ameliorated Dyslipidemia among Sickle Cell Anemia Patients. J Lipids. 2019 Jun 18;2019:3129461. doi: 10.1155/2019/3129461. eCollection 2019.
• Kaddam LA, Fdl-Elmula I, Eisawi OA, Abdelrazig HA, Elnimeiri MK, Saeed AM. Biochemical effects and safety of Gum arabic (Acacia Senegal) supplementation in patients with sickle cell anemia. Blood Res. 2019 Mar;54(1):31-37. doi: 10.5045/br.2019.54.1.31. Epub 2019 Mar 21.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 5, 2015): 47
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 2015
• Actual Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. over 5 year old
2. less t5han 50
3. diagnosed with homozygous sickle cell anemia by Hb electrophoresis

Exclusion Criteria:

1. patients received blood transfusion within the last three months or admitted to the hospital within 2 weeks because of Sickle cell anemia -related events or crisis.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 5 Years to 50 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: NCT02467257
• Other Study ID Numbers: AlNeelainU
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Lamis Kaddam, Al-Neelain University
• Original Responsible Party: Same as current
• Current Study Sponsor: Al-Neelain University
• Original Study Sponsor: Same as current

Collaborators

• Military hospital
• Ministry of Higher Education and Scientific Research, Republic of Sudan

Investigators

• Study Director: Amal M Saeed, PhD; University of Khartoum Faculty of Medicine Department of Physiology
• Principal Investigator: Lamis AA Kaddam, MSc; Department of physiology Faculty of Medicine Alneelain University Khartoum,

• PRS Account: Al-Neelain University
• Verification Date: June 2015