Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Khartoum | OTHER |
Not provided
Not provided
Not provided
Not provided
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
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acacia Senegal extract | Dietary Supplement | Oral Digestion of Gum Arabic to be consumed early morning in daily basis for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fetal hemoglobin level after 12 weeks | Measure increase from the baseline values | 12 weeks |
| Total anti oxidant capacity | Measure increase from the baseline values | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Anti inflammatory marker C reactive Protein | Measure decrease from the baseline values | 12 weeks |
Not provided
Inclusion Criteria:
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.
Exclusion Criteria:
Patients who are currently using Gum Arabic. Patients who are on steroids or chemotherapy.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dalya MM Abdelmaged, MBBS | Contact | 00249126831595 | dalya.alfeel@gmail.com | |
| Lamis AA KAddam, PhD | Contact | +249912979736 | lamiskaddam@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Imad M Fdl-Elmula, PhD | Alneelain University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Military Hospital | Recruiting | Omdurman | Khartoum State | 1113 | Sudan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26719803 | Background | 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. | |
| 28331623 | Background | 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. |
Not provided
Not provided
Share patients data without personal data and without breaching confidentiality
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D017086 | beta-Thalassemia |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006170 | Gum Arabic |
| D010368 | Pectins |
| ID | Term |
|---|---|
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
Not provided
Not provided
The intervention group will receive Gum Arabic. And The placebo group will receive pectin
Not provided
Not provided
Participants, care providers, Investigator and outcome assessor will be masked regarding the type of intervention each group will receive
| Pectin | Dietary Supplement | Oral Digestion of Pectin to be consumed early morning in daily basis for 12 weeks |
|
| 30112005 | Background | Kamal 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. |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013789 | Thalassemia |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |