Sickle Cell AnemiaPhase 1/2NCT02467257
Gum Arabic as Fetal Hemoglobin Agent in Sickle Cell Anemia
A Phase 1/2 study testing Gum Arabic in people with Sickle Cell Anemia, run by Al-Neelain University at 1 site in Sudan.
Trial summary
The purpose of this study is to determine whether Gum Arabic is effective as fetal hemoglobin inducing agent for sickle cell anemia patients. Read more about this study
- Who is it for?
- Ages 5 to 50 years
- Conditions the study is for
- Sickle Cell Anemia
- What is being tested?
- Gum Arabic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSudan
- Study dates
- Apr 2014to Jan 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- over 5 year old
- less t5han 50
- diagnosed with homozygous sickle cell anemia by Hb electrophoresis
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Potential Role of Gum Arabic as Fetal Hemoglobin Agent in Sudanese Sickle Cell Anemia Patients
The purpose of this study is to determine whether Gum Arabic is effective as fetal hemoglobin inducing agent for sickle cell anemia patients.
Read the 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.
- Conditions
- Sickle Cell Anemia
- Being tested
- Gum Arabic
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gum ArabicDietary supplement
oral ingestion of 30 gram every day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intrevention arm | Experimental | Patients received Gum Arabic as intervention Receives: Dietary Supplement: Gum Arabic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startApr 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Neelain University
- Sponsor type
- University, hospital or other
- Collaborators
- Military hospital, Ministry of Higher Education and Scientific Research, Republic of Sudan
- Responsible party
- Principal investigator, Lamis Kaddam, Al-Neelain University
- Investigators
- Amal M Saeed, PhD, Study director, University of Khartoum Faculty of Medicine Department of PhysiologyLamis AA Kaddam, MSc, Principal investigator, Department of physiology Faculty of Medicine Alneelain University Khartoum,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467257
- Sponsor's protocol ID
- AlNeelainU
- Status last verified
- Jun 2015
- First submitted
- 4 Jun 2015
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 17124041Kutlar 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.
PubMed 23828223Matsumoto 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.
PubMed 16408114Ballal 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.
PubMed 21599958Kaddam 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.
PubMed 32188508Kaddam 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.
PubMed 31316836Kaddam 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.
PubMed 30956961Kaddam 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.
PubMed 28331623Kaddam 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.
PubMed 26719803
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Role of Gum Arabic as Fetal Hemoglobin Agent in Sudanese Sickle Cell Anemia Patients
- ClinicalTrials.gov ID
- NCT02467257
- Acronym / sponsor ID
- AlNeelainU
- Conditions
- Sickle Cell Anemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Al-Neelain UniversityUniversity, hospital or other
- Collaborators
- Military hospital, Ministry of Higher Education and Scientific Research, Republic of Sudan
- Study start
- Apr 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intrevention arm | Experimental | Dietary Supplement: Gum ArabicPatients received Gum Arabic as intervention |
Who may qualify
- Ages
- 5 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- over 5 year old
- less t5han 50
- diagnosed with homozygous sickle cell anemia by Hb electrophoresis
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gum Arabicoral ingestion of 30 gram every day for 12 weeks | Dietary supplement | Intrevention arm |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
- Background: PubMed 17124041Fathallah 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.
- Background: PubMed 23828223Kutlar 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.
- Background: PubMed 16408114Matsumoto 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.
- Background: PubMed 21599958Ballal 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.
- Derived from this study: PubMed 32188508Kaddam 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.
- Derived from this study: PubMed 31316836Kaddam 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.
- Derived from this study: PubMed 30956961Kaddam 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.
- Derived from this study: PubMed 28331623Kaddam 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.
- Derived from this study: PubMed 26719803Kaddam 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal M Saeed, PhD study director
University of Khartoum Faculty of Medicine Department of Physiology
Lamis AA Kaddam, MSc principal investigator
Department of physiology Faculty of Medicine Alneelain University Khartoum,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gum Arabic in people with Sickle Cell Anemia, run by Al-Neelain University at 1 site in Sudan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sudan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of the study will be the level of fetal hemoglobin after three months (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02467257, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2015.