Sickle Cell Anemia in ChildrenPhase 2/3GA&SCANCT04191213
Gum Arabic as Anti-oxidant, Anti-inflammatory and Fetal Hemoglobin Inducing Agent in Sickle Cell Anemia Patients
A Phase 2/3 study testing Acacia Senegal extract and Pectin in people with Sickle Cell Anemia in Children, run by Al-Neelain University at 1 site in Sudan.
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 Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Sickle Cell Anemia in Children
- What is being tested?
- Acacia Senegal extract and Pectin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSudan
- Study dates
- 15 Feb 2020to 15 Jul 2020
- Phase
- Phase 2/3
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sudan1 site, 1 recruiting
- Recruiting
Military Hospital
Omdurman, Khartoum State, 1113
Haydar A Abdelrazig, MD, 249123431031, habdelhakam1@hotmail.com
Haydar A Abdelrazig, MD
About this study
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
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
Read the detailed 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
- Conditions
- Sickle Cell Anemia in Children
- Being tested
- Acacia Senegal extract, Pectin
- Keywords
- sickle cell anemia, Gum Arabic, Fetal Hemoglobin
- Medical subject headings
- Anemia, Sickle Cell, beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acacia Senegal extractDietary supplement
Also called (Gum Arabic)
Oral Digestion of Gum Arabic to be consumed early morning in daily basis for 12 weeks
PectinDietary supplement
Oral Digestion of Pectin to be consumed early morning in daily basis for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | This arm will receive 100% natural Gum Arabic provided in a powder form in 30-grams-dose for participants above 5 years of age and 15-grams-dose for participants below 5 years of age for 12 weeks Receives: Dietary Supplement: Acacia Senegal extract |
| Control group | Placebo comparator | This group will be provided with pectin powder provided as one-gram-dose for children below 5 years of age \& two-gram-dose for children above 5 years of age Receives: Dietary Supplement: Pectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal hemoglobin level after 12 weeks
Measure increase from the baseline values
Measured: 12 weeks
Total anti oxidant capacity
Measure increase from the baseline values
Measured: 12 weeks
Secondary outcomes (1)
Anti inflammatory marker C reactive Protein
Measure decrease from the baseline values
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 posted9 Dec 2019
- Study start15 Feb 2020 (estimated)
- Primary completion15 Jun 2020 (estimated)
- Study completion15 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell Anemia in ChildrenStudies 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group will receive Gum Arabic. And The placebo group will receive pectin
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Neelain University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Khartoum
- Responsible party
- Principal investigator, Lamis Kaddam, Al-Neelain University
- Investigators
- Imad M Fdl-Elmula, PhD, Study director, Alneelain University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191213
- Sponsor's protocol ID
- GA& Sickle among children
- Acronym
- GA&SCA
- Status last verified
- Jan 2020
- First submitted
- 5 Dec 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Share patients data without personal data and without breaching confidentiality
Publications
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.
PubMed 26719803Kaddam 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 28331623Kamal 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.
PubMed 30112005
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04191213
- Acronym / sponsor ID
- GA&SCA / GA& Sickle among children
- Conditions
- Sickle Cell Anemia in Children
- Keywords
- sickle cell anemia, Gum Arabic, Fetal Hemoglobin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Al-Neelain UniversityUniversity, hospital or other
- Collaborators
- University of Khartoum
- Study start
- 15 Feb 2020 (estimated)
- Primary completion
- 15 Jun 2020 (estimated)
- Study completion
- 15 Jul 2020 (estimated)
- First posted
- 9 Dec 2019 (actual)
- 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.
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
Detailed 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention group will receive Gum Arabic. And The placebo group will receive pectin
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Acacia Senegal extractThis arm will receive 100% natural Gum Arabic provided in a powder form in 30-grams-dose for participants above 5 years of age and 15-grams-dose for participants below 5 years of age for 12 weeks |
| Control group | Placebo comparator | Dietary Supplement: PectinThis group will be provided with pectin powder provided as one-gram-dose for children below 5 years of age \& two-gram-dose for children above 5 years of age |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Acacia Senegal extractAlso: (Gum Arabic)Oral Digestion of Gum Arabic to be consumed early morning in daily basis for 12 weeks | Dietary supplement | Intervention Group |
| PectinOral Digestion of Pectin to be consumed early morning in daily basis for 12 weeks | Dietary supplement | Control group |
Primary outcome
Fetal hemoglobin level after 12 weeks
Time frame: 12 weeks
Measure increase from the baseline values
Total anti oxidant capacity
Time frame: 12 weeks
Measure increase from the baseline values
1 secondary outcome
Anti inflammatory marker C reactive Protein
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Background: 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.
- Background: 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.
- Background: PubMed 30112005Kamal 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.
- Individual participant dataSharing planned: Undecided. Share patients data without personal data and without breaching confidentiality
Related trials for Sickle Cell Anemia in Children
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
Not yet recruiting
Hypoxic Red Blood Cells in Sickle Cell Anemia
Sickle Cell Anaemia, Sickle Cell Anemia Crisis
Active, not recruitingPhase 2
Stroke Prevention With Hydroxyurea Enabled Through Research and Education (SPHERE)
Sickle Cell Anemia in Children
Recruiting
Exercise in Child Health
Cystic Fibrosis, Sickle Cell Disease
RecruitingPhase 2
Pharmacokinetics, Efficacy and Safety of Twice Daily Dosing Regimen of Hydroxycarbamide Dispersible Tablets in Children With Sickle Cell Disease
Sickle Cell Disease
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.
Imad M Fdl-Elmula, PhD study director
Alneelain University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Acacia Senegal extract and Pectin in people with Sickle Cell Anemia in Children, 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 2 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: status not confirmed, as of the sponsor's last update on 28 Jan 2020. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalya MM Abdelmaged, MBBS (00249126831595, dalya.alfeel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal hemoglobin level after 12 weeks (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT04191213, which also lists 3 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 28 Jan 2020.