Dataset Information

Gum Arabic as novel anti-oxidant agent in sickle cell anemia, phase II trial.

ABSTRACT:

Background

Sickle cell anemia patients suffer from oxidative stress due to chronic inflammation and self-oxidation of sickle hemoglobin (Hb S). Chronic oxidative stress contributes to endothelial dysfunction, inflammation and multiple organ damage in sickle cell disease (SCD). Thus, antioxidant medication may favorably influence the disease. Gum Arabic (GA), edible, dried, gummy exudates from Acacia Senegal tree, has been claimed to act as an anti-oxidant and cytoprotective agent, protecting against experimental hepatic, renal and cardiac toxicities in rats. We hypothesized that regular intake of GA increases anti-oxidant capacity and reduce oxidative stress.

Methods

Forty-seven patients (5-42 years) carrying hemoglobin SS were recruited. Patients received 30 g/day GA for 12 weeks. Total anti-oxidant capacity (TAC), malondialdehyde (MDA) and hydrogen peroxide (H₂O₂) levels were measured by spectrophotometric methods before and after GA intake. Complete blood count was measured by sysmex.

Results

Gum Arabic significantly increased TAC level P < 0.001and decreased the oxidative markers MDA (P < 0.05) and H₂O₂ (P < 0.005).

Conclusions

GA has potent anti- oxidative properties in sickle cell anemia. The anti-oxidant effect of GA may thus favorably influence the clinical condition of this and further diseases characterized by oxidative stress.

Trial registration

ClinicalTrials.gov Identifier: NCT02467257. Registered 3rd June 2015. Retrospective registration.

SUBMITTER: Kaddam L

PROVIDER: S-EPMC5356407 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Publications

Gum Arabic as novel anti-oxidant agent in sickle cell anemia, phase II trial.

Kaddam Lamis L Fadl-Elmula Imad I Eisawi Omer Ali OA Abdelrazig Haydar Awad HA Salih Mohammed Abdelraman MA Lang Florian F Saeed Amal M AM

BMC hematology 20170316

<h4>Background</h4>Sickle cell anemia patients suffer from oxidative stress due to chronic inflammation and self-oxidation of sickle hemoglobin (Hb S). Chronic oxidative stress contributes to endothelial dysfunction, inflammation and multiple organ damage in sickle cell disease (SCD). Thus, antioxidant medication may favorably influence the disease. Gum Arabic (GA), edible, dried, gummy exudates from Acacia Senegal tree, has been claimed to act as an anti-oxidant and cytoprotective agent, protec ...[more]

PMID: 28331623

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Project description:BackgroundSickle cell disease (SCD) is an inherited haemolytic anemia with a variable course and severity. Knowledge of prognostic biomarkers may help in the establishment of therapeutic intervention, management, and follow-up of patients. There have been scattered reports of low high-density lipoprotein cholesterol (HDL-C) and increased triglyceride (TG) in SCD patients. In addition, TG levels have been suggested to be elevated in patients with increased endothelial activation. An increased TG level has been associated with haemolysis, vascular dysfunction, and increased prevalence of pulmonary hypertension. Gum Arabic (GA) is an edible, dried, gummy exudate from the acacia Senegal tree. Several studies on GA ingestion have shown reduced plasma cholesterol and low-density lipoprotein (LDL) concentrations in both animals and humans. We investigated GA's therapeutic potential to modulate serum lipids in patients with sickle cell anemia.MethodsThis study recruited and documented secondary outcomes in 47 patients (aged 5-42 years) carrying hemoglobin SS. The patients received 30 g/day of GA for 12 weeks. Total cholesterol, TG, LDL, and HDL were measured before and after GA intake. Cobas C311 (Roche, Germany) automated chemistry analyser was used for direct determination of the values of the lipid profile.ResultsGA significantly decreased total cholesterol (TC), TG, and LDL (p = 0.006, 0.04, and 0.02, resp.). GA showed no effect on HDL level. Baseline serum TG and LDL correlated significantly with the hydrogen peroxide (H2O2) level, which is known as an oxidative stress marker (p = 0.003 and 0.04, resp.). None of the lipid profile elements correlated with age.ConclusionOur results revealed that dyslipidemia in sickle cell patients is associated with oxidative stress but not associated with age. The findings showed that GA significantly decreased TC, LDL, and TG levels, revealing a novel effect of GA, which is considered a natural dietary fibre that can modulate lipid profile in patients with sickle cell anemia.Trial registrationThis retrospective trial is registered with ClinicalTrials.gov Identifier: NCT02467257 on 3 June, 2015.

Project description:Background: Rheumatoid arthritis (RA) is an autoimmune disease that mainly affects the synovial joints with systemic manifestations. RA has a major impact on liver and kidney functions as part of the disease pathogenesis or as a sequel of disease medications or, mostly, both of them. The kidney and liver involvement increases the RA morbidity and mortality. Nowadays, dietary interventions are proposed as potential modifiers for disease severity. Gum Arabic (GA) is acacia senegal exudates; it is soluble fiber with prebiotic properties. GA has been discovered to be protective against experimental nephrotoxicity and hepatotoxicity, with comparable findings in human studies. This article addresses the effect of GA on hepatic and renal profile among RA patients. Methods: Forty patients aged 18-70 received GA daily for 12 weeks as a single dose of 30 g. The liver enzymes, total protein level, serum albumin, serum globulin level, urea, creatinine, and serum electrolytes have been measured as a baseline after 4 weeks and by the end of the study. Cobas C311 (Roche, Germany) automated chemistry analyzer directly determined the values for total protein, albumin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and creatinine. The study ethically has been approved by the Ethical Committee of the National Medicines and Poisons Board. Trial Registration Identifier: NCT02804581. Results: Regarding the liver enzymes, GA has significantly decreased the liver enzymes apart from alkaline phosphatase, which showed no significant change. In contrast, GA has increased the serum albumin level with a minor impact on the serum globulin level. Furthermore, GA has also significantly decreased the level of urea (P = 0.0001) and level of Sodium (P = 0.002) with nonsignificant change on creatinine and potassium concentrations. Conclusion: GA presents hepatic and renal protective effects among RA patients, evidenced by the significant reduction of urea and liver enzymes. Thus, it can be recommended as a dietary supplement for RA patients. Nonetheless, we recommend further investigation to support our findings.

Project description:BackgroundCerebral vasculopathy in sickle cell anemia (SCA) begins in childhood and features intracranial arterial stenosis with high risk of ischemic stroke. Stroke risk can be reduced by transcranial doppler (TCD) screening and chronic transfusion therapy; however, this approach is impractical in many developing countries. Accumulating evidence supports the use of hydroxyurea for the prevention and treatment of cerebrovascular disease in children with SCA. Recently we reported that hydroxyurea significantly reduced the conversion from conditional TCD velocities to abnormal velocities; whether hydroxyurea can be used for children with newly diagnosed severe cerebrovascular disease in place of starting transfusion therapy remains unknown.ObjectiveThe primary objective of the EXpanding Treatment for Existing Neurological Disease (EXTEND) trial is to investigate the effect of open label hydroxyurea on the maximum time-averaged mean velocity (TAMV) after 18 months of treatment compared to the pre-treatment value. Secondary objectives include the effects of hydroxyurea on serial TCD velocities, the incidence of neurological and non-neurological events, quality of life (QOL), body composition and metabolism, toxicity and treatment response, changes to brain magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA), genetic and serologic markers of disease severity, and cognitive and pulmonary function.MethodsThis prospective Phase II trial will enroll children with SCA in Jamaica, between the ages of 2 and 17 years, with either conditional (170-199 cm/sec) or abnormal (≥ 200 cm/sec) TCD velocities. Oral hydroxyurea will be administered daily and escalated to the maximum tolerated dose (MTD). Participants will be seen in the Sickle Cell Unit (SCU) in Kingston, Jamaica monthly until achieving MTD, and then every 3 months. TCD will be performed every 6 months.ResultsCurrently, 43 participants have been enrolled out of a projected 50. There was one withdrawal due to immigration, with no permanent screen failures. Of the 43 enrolled, 37 participants have initiated study treatment.ConclusionsThis trial investigates the effects of hydroxyurea treatment at MTD in children with conditional or abnormal TCD velocities before transfusion therapy and may represent an important advance towards establishing a suitable non-transfusion protocol for stroke prevention in children with SCA. The trial outcomes will have profound significance in developing countries where the disease burden is highest.ClinicaltrialClinicalTrials.gov NCT02556099; https://clinicaltrials.gov/ct2/show/NCT02556099 (Archived by WebCite at http://www.webcitation.org/6k1yMAa9G).

Dataset Information

Gum Arabic as novel anti-oxidant agent in sickle cell anemia, phase II trial.

Background

Methods

Results

Conclusions

Trial registration

Publications

Gum Arabic as novel anti-oxidant agent in sickle cell anemia, phase II trial.

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