Gum Arabic as Fetal Hemoglobin Agent in Sickle Cell Anemia

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ClinicalTrials.gov Identifier: NCT02467257

Recruitment Status : Completed

First Posted : June 10, 2015

Last Update Posted : June 10, 2015

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Sponsor:

Collaborators:

Military hospital

Ministry of Higher Education and Scientific Research, Republic of Sudan

Information provided by (Responsible Party):

Lamis Kaddam, Al-Neelain University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sickle Cell Anemia	Dietary Supplement: Gum Arabic	Phase 1 Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	47 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Potential Role of Gum Arabic as Fetal Hemoglobin Agent in Sudanese Sickle Cell Anemia Patients
Study Start Date :	April 2014
Actual Primary Completion Date :	January 2015
Actual Study Completion Date :	January 2015

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Sickle cell disease

MedlinePlus related topics: Anemia

Genetic and Rare Diseases Information Center resources: Sickle Cell Anemia

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intrevention arm Patients received Gum Arabic as intervention	Dietary Supplement: Gum Arabic oral ingestion of 30 gram every day for 12 weeks

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	5 Years to 50 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

over 5 year old
less t5han 50
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02467257

Locations

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Sudan
Military Hospital
Omdurman, Khartoum, Sudan, 1113

Sponsors and Collaborators

Al-Neelain University

Military hospital

Ministry of Higher Education and Scientific Research, Republic of Sudan

Investigators

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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,

More Information

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Lamis Kaddam, Dr, Al-Neelain University
ClinicalTrials.gov Identifier:	NCT02467257
Other Study ID Numbers:	AlNeelainU
First Posted:	June 10, 2015 Key Record Dates
Last Update Posted:	June 10, 2015
Last Verified:	June 2015

Additional relevant MeSH terms:

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Anemia Anemia, Sickle Cell Hematologic Diseases Anemia, Hemolytic, Congenital	Anemia, Hemolytic Hemoglobinopathies Genetic Diseases, Inborn

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