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Gum Arabic as Fetal Hemoglobin Agent in Sickle Cell Anemia

Primary Purpose

Sickle Cell Anemia

Status
Completed
Phase
Phase 1
Locations
Sudan
Study Type
Interventional
Intervention
Gum Arabic
Sponsored by
Al-Neelain University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Anemia

Eligibility Criteria

5 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Military Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intrevention arm

Arm Description

Patients received Gum Arabic as intervention

Outcomes

Primary Outcome Measures

The primary endpoint of the study will be the level of fetal hemoglobin after three months
fetal hemoglobin will be measured each month for three months

Secondary Outcome Measures

Full Information

First Posted
June 4, 2015
Last Updated
June 5, 2015
Sponsor
Al-Neelain University
Collaborators
Military hospital, Ministry of Higher Education and Scientific Research, Republic of Sudan
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1. Study Identification

Unique Protocol Identification Number
NCT02467257
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Neelain University
Collaborators
Military hospital, Ministry of Higher Education and Scientific Research, Republic of Sudan

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intrevention arm
Arm Type
Experimental
Arm Description
Patients received Gum Arabic as intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Gum Arabic
Intervention Description
oral ingestion of 30 gram every day for 12 weeks
Primary Outcome Measure Information:
Title
The primary endpoint of the study will be the level of fetal hemoglobin after three months
Description
fetal hemoglobin will be measured each month for three months
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal M Saeed, PhD
Organizational Affiliation
University of Khartoum Faculty of Medicine Department of Physiology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lamis AA Kaddam, MSc
Organizational Affiliation
Department of physiology Faculty of Medicine Alneelain University Khartoum,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Military Hospital
City
Omdurman
State/Province
Khartoum
ZIP/Postal Code
1113
Country
Sudan

12. IPD Sharing Statement

Citations:
PubMed Identifier
17124041
Citation
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.
Results Reference
background
PubMed Identifier
23828223
Citation
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.
Results Reference
background
PubMed Identifier
16408114
Citation
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.
Results Reference
background
PubMed Identifier
21599958
Citation
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.
Results Reference
background
PubMed Identifier
32188508
Citation
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.
Results Reference
derived
PubMed Identifier
31316836
Citation
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.
Results Reference
derived
PubMed Identifier
30956961
Citation
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.
Results Reference
derived
PubMed Identifier
28331623
Citation
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.
Results Reference
derived
PubMed Identifier
26719803
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.
Results Reference
derived

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Gum Arabic as Fetal Hemoglobin Agent in Sickle Cell Anemia

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