End-Stage Renal DiseaseGA&CRFNCT03214692
Gum Arabic as Antioxidant and Anti-inflammatory in Hemodialysis Patients
A study testing Gum Arabic in people with End-Stage Renal Disease, run by Lamis Kaddam at 1 site in Sudan.
Trial summary
Oxidative processes increased in patients with renal failure and especially patients with end stage renal failure on dialysis. Oxidative stress plays a role in renal damage and also on cardiovascular disease, atherosclerosis, which can accelerate renal damage. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End-Stage Renal Disease
- 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
- 50 participants
- Where
- 1 siteSudan
- Study dates
- Jul 2017to Oct 2017
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End stage renal disease patients on regular hemodialysis.
Who cannot join
- Patient known have ischemic heart disease (coronary artery disease),
- Pregnant women,
- Patient who have impaired liver function or hepatitis VIRUS positive,
- Patient who HIV positive and patient currently use of GUM Arabic.
Trial locations and contacts
1 site in 1 country.
Sudan1 site
Military Hospital AlshaheedArif renal center
Khartoum, Umdorman, 1121
About this study
Official title: Potential Role of Gum Arabic as Antioxidant and Anti-inflammatory Agent in Hemodialysis Patients
Oxidative processes increased in patients with renal failure and especially patients with end stage renal failure on dialysis. Oxidative stress plays a role in renal damage and also on cardiovascular disease, atherosclerosis, which can accelerate renal damage. Gum Arabic is claimed to have antioxidant effect and this will decrease the harmful effect of the free radical on patient on hemodialysis. In this study investigators are aiming to see the effect of Gum Arabic on Oxidative Stress and inflammatory markers in patients on regular hemodialysis.
Read the detailed description
The oxidative stress reflects an imbalance between the systemic manifestation of reactive oxygen species and a biological system's ability to readily detoxify the reactive intermediates or to repair the resulting damage.
Cells continuously produce free radicals and reactive oxygen species (ROS) as part of metabolic processes. These free radicals are neutralized by an elaborate antioxidant defense system consisting of enzymes such as catalase, superoxide dismutase, glutathione peroxidase, and numerous non-enzymatic antioxidants, including vitamins A, E and C and glutathione.
Oxidative stress has been linked to the pathogenesis of a variety of diseases, such as renal disease, cardiovascular disease, atherosclerosis, hypertension, cancer, diabetes, arthritis neurodegenerative diseases (i.e., Alzheimer's and Parkinson's disease), and aging.
The prevalence and incidence of patient suffering from chronic renal failure is increasing worldwide and locally in Sudan(5). Several publication suggest that oxidative processes may be increased in patients with renal failure. As oxidative stress plays a role in renal damage it offers a potential target for therapeutic intervention.
There is a lot of factors that can lead to oxidative stress in patients with chronic kidney disease (CKD) . Intravenous administration of iron is widely prescribed in patients with chronic kidney disease (CKD) and can cause oxidative stress.Hemodialysis is often used for removal of excessive toxins, metabolic products, and blood components from patients with end-stage renal diseases (ESRD). Clinical studies have confirmed that hemodialysis (HD) is associated with the development of oxidative stress and disturbance in the enzyme systems that protect against oxygen free radicals.
The major cause of mortality in patients with end-stage renal failure receiving renal replacement therapy is cardiovascular disease . Cardiovascular disease (CVD) is the cause of death in 34% of hemodialysis (HD) patients. Increased lipid peroxidation and depletion of chain- breaking antioxidants may contribute to increased risk of atherosclerosis.
Antioxidants have been used as therapies to decrease oxidative stress and improve CVD risk in hemodialysis (HD) Patients .Many studies investigated the effects of antioxidant therapies on biomarkers of oxidative stress or clinical outcomes. The majority were small trials using a nonrandomized open-label design with a single HD group (no HD controls). The antioxidant used were Alpha-tocopherol , vitamin c decreased oxidative stress and N-acetylcysteine . N-acetylcysteine was the most efficacious agent. Others studies have used a combination of antioxidants that decreased oxidative stresses. Most of these intervention studies were done in HD patients .
Gum arabic is defined by the FAO/WHO Joint Expert Committee for Food Additives (JECFA) as 'a dried exudation obtained from the stems of Acacia Senegal tree or closely related species of Acacia (family Leguminosae).
GA is indigestible for both human and animals; Its fermentation by colonic intestinal bacteria leads to formation of various degradation products, such as short-chain fatty acids .Gum Arabic ingestion increases serum short chain fatty acid concentration, mainly butyrate and propionate. Serum butyrate concentration increased following administration of GA in healthy subjects. Oral intake of GA has been shown to provide several health benefits, such as prebiotic effects. GA significantly increases Bifidobacteria, Lactobacteria, and Bacteriodes in the gut. GA is claimed to have anti-cancer ,anti-malarial immune-modulatory and antioxidant effects. GA treatment has been shown to favorably influence clinical and laboratory results in rats with adenine-induced chronic renal failure CRF and in humans diagnosed with renal failure, reported that GA was able to decrease high levels of several pro-inflammatory cytokines in plasma and kidney of rats suffering from adenine-induced CRF.
The antioxidant effect of Gum Arabic has been observed in Number of published data .
More recently 2017 reported more evidence that GA has potent anti- oxidative effects in humans as demonstrated by its ability to increase TAC and to decrease oxidative stress markers in humans, Almost all previous studies were conducted in animal models or in vitro studies except the last one(17) . the increased intake of dietary antioxidants from GA may help to maintain an adequate antioxidant defense status . GA can be utilized in other clinical conditions and diseases caused by increased lipid peroxidation and tissue injury.
In this study investigators are aiming to see the effect of Gum Arabic on Oxidative Stress and inflammatory markers in patients on regular hemodialysis.
- Conditions
- End-Stage Renal Disease
- Being tested
- Gum Arabic
- Keywords
- Gum Arabic, Renal failure, Hemodialysis, Antioxidant and anti-inflammatory
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gum ArabicDietary supplement
Oral intake of GA in powder from30 grams per day
| Study group | Role | What they receive |
|---|---|---|
| Gum Arabic | Experimental | The patients will receive 30 grams of Gum Arabic dissolved in 200 ml of water to ingest orally Receives: Dietary Supplement: Gum Arabic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Tumor necrosis factor alpha
pg/mL
Measured: Baseline and after 12 weeks
Change from baseline Oxidative stress marker malondialdehyde
nmol/mL
Measured: Baseline and after 12 weeks
Secondary outcomes (1)
Glomerular Filtration Rate (GFR)
ml/ minute
Measured: Baseline and every four weeks for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study startJul 2017 (estimated)
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (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 End-Stage Renal DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Daily ingestion of Gum Arabic for 12 weeks
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lamis Kaddam
- Sponsor type
- University, hospital or other
- Collaborators
- Military Hospital Sudan, University of Khartoum
- Responsible party
- Sponsor-investigator, Lamis Kaddam, Al-Neelain University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214692
- Sponsor's protocol ID
- GA&CRF
- Acronym
- GA&CRF
- Status last verified
- Jul 2017
- First submitted
- 18 Jun 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28331623Ali BH, Al-Husseni I, Beegam S, Al-Shukaili A, Nemmar A, Schierling S, Queisser N, Schupp N. Effect of gum arabic on oxidative stress and inflammation in adenine-induced chronic renal failure in rats. PLoS One. 2013;8(2):e55242. doi: 10.1371/journal.pone.0055242. Epub 2013 Feb 1.
PubMed 23383316Ali NE, Kaddam LA, Alkarib SY, Kaballo BG, Khalid SA, Higawee A, AbdElhabib A, AlaaAldeen A, Phillips AO, Saeed AM. Gum Arabic (Acacia Senegal) Augmented Total Antioxidant Capacity and Reduced C-Reactive Protein among Haemodialysis Patients in Phase II Trial. Int J Nephrol. 2020 Apr 9;2020:7214673. doi: 10.1155/2020/7214673. eCollection 2020.
PubMed 32328307
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Role of Gum Arabic as Antioxidant and Anti-inflammatory Agent in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03214692
- Acronym / sponsor ID
- GA&CRF / GA&CRF
- Conditions
- End-Stage Renal Disease
- Keywords
- Gum Arabic, Renal failure, Hemodialysis, Antioxidant and anti-inflammatory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Lamis KaddamUniversity, hospital or other
- Collaborators
- Military Hospital Sudan, University of Khartoum
- Study start
- Jul 2017 (estimated)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 11 Jul 2017 (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.
Oxidative processes increased in patients with renal failure and especially patients with end stage renal failure on dialysis. Oxidative stress plays a role in renal damage and also on cardiovascular disease, atherosclerosis, which can accelerate renal damage. Gum Arabic is claimed to have antioxidant effect and this will decrease the harmful effect of the free radical on patient on hemodialysis. In this study investigators are aiming to see the effect of Gum Arabic on Oxidative Stress and inflammatory markers in patients on regular hemodialysis.
Detailed description
The oxidative stress reflects an imbalance between the systemic manifestation of reactive oxygen species and a biological system's ability to readily detoxify the reactive intermediates or to repair the resulting damage.
Cells continuously produce free radicals and reactive oxygen species (ROS) as part of metabolic processes. These free radicals are neutralized by an elaborate antioxidant defense system consisting of enzymes such as catalase, superoxide dismutase, glutathione peroxidase, and numerous non-enzymatic antioxidants, including vitamins A, E and C and glutathione.
Oxidative stress has been linked to the pathogenesis of a variety of diseases, such as renal disease, cardiovascular disease, atherosclerosis, hypertension, cancer, diabetes, arthritis neurodegenerative diseases (i.e., Alzheimer's and Parkinson's disease), and aging.
The prevalence and incidence of patient suffering from chronic renal failure is increasing worldwide and locally in Sudan(5). Several publication suggest that oxidative processes may be increased in patients with renal failure. As oxidative stress plays a role in renal damage it offers a potential target for therapeutic intervention.
There is a lot of factors that can lead to oxidative stress in patients with chronic kidney disease (CKD) . Intravenous administration of iron is widely prescribed in patients with chronic kidney disease (CKD) and can cause oxidative stress.Hemodialysis is often used for removal of excessive toxins, metabolic products, and blood components from patients with end-stage renal diseases (ESRD). Clinical studies have confirmed that hemodialysis (HD) is associated with the development of oxidative stress and disturbance in the enzyme systems that protect against oxygen free radicals.
The major cause of mortality in patients with end-stage renal failure receiving renal replacement therapy is cardiovascular disease . Cardiovascular disease (CVD) is the cause of death in 34% of hemodialysis (HD) patients. Increased lipid peroxidation and depletion of chain- breaking antioxidants may contribute to increased risk of atherosclerosis.
Antioxidants have been used as therapies to decrease oxidative stress and improve CVD risk in hemodialysis (HD) Patients .Many studies investigated the effects of antioxidant therapies on biomarkers of oxidative stress or clinical outcomes. The majority were small trials using a nonrandomized open-label design with a single HD group (no HD controls). The antioxidant used were Alpha-tocopherol , vitamin c decreased oxidative stress and N-acetylcysteine . N-acetylcysteine was the most efficacious agent. Others studies have used a combination of antioxidants that decreased oxidative stresses. Most of these intervention studies were done in HD patients .
Gum arabic is defined by the FAO/WHO Joint Expert Committee for Food Additives (JECFA) as 'a dried exudation obtained from the stems of Acacia Senegal tree or closely related species of Acacia (family Leguminosae).
GA is indigestible for both human and animals; Its fermentation by colonic intestinal bacteria leads to formation of various degradation products, such as short-chain fatty acids .Gum Arabic ingestion increases serum short chain fatty acid concentration, mainly butyrate and propionate. Serum butyrate concentration increased following administration of GA in healthy subjects. Oral intake of GA has been shown to provide several health benefits, such as prebiotic effects. GA significantly increases Bifidobacteria, Lactobacteria, and Bacteriodes in the gut. GA is claimed to have anti-cancer ,anti-malarial immune-modulatory and antioxidant effects. GA treatment has been shown to favorably influence clinical and laboratory results in rats with adenine-induced chronic renal failure CRF and in humans diagnosed with renal failure, reported that GA was able to decrease high levels of several pro-inflammatory cytokines in plasma and kidney of rats suffering from adenine-induced CRF.
The antioxidant effect of Gum Arabic has been observed in Number of published data .
More recently 2017 reported more evidence that GA has potent anti- oxidative effects in humans as demonstrated by its ability to increase TAC and to decrease oxidative stress markers in humans, Almost all previous studies were conducted in animal models or in vitro studies except the last one(17) . the increased intake of dietary antioxidants from GA may help to maintain an adequate antioxidant defense status . GA can be utilized in other clinical conditions and diseases caused by increased lipid peroxidation and tissue injury.
In this study investigators are aiming to see the effect of Gum Arabic on Oxidative Stress and inflammatory markers in patients on regular hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Daily ingestion of Gum Arabic for 12 weeks
| Arm | Type | Receives |
|---|---|---|
| Gum Arabic | Experimental | Dietary Supplement: Gum ArabicThe patients will receive 30 grams of Gum Arabic dissolved in 200 ml of water to ingest orally |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- End stage renal disease patients on regular hemodialysis.
Key exclusion criteria (4 listed)
- Patient known have ischemic heart disease (coronary artery disease),
- Pregnant women,
- Patient who have impaired liver function or hepatitis VIRUS positive,
- Patient who HIV positive and patient currently use of GUM Arabic.
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 intake of GA in powder from30 grams per day | Dietary supplement | Gum Arabic |
Primary outcome
Change from baseline Tumor necrosis factor alpha
Time frame: Baseline and after 12 weeks
pg/mL
Change from baseline Oxidative stress marker malondialdehyde
Time frame: Baseline and after 12 weeks
nmol/mL
1 secondary outcome
Glomerular Filtration Rate (GFR)
Time frame: Baseline and every four weeks for 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Results publication: 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.
- Results publication: PubMed 23383316Ali BH, Al-Husseni I, Beegam S, Al-Shukaili A, Nemmar A, Schierling S, Queisser N, Schupp N. Effect of gum arabic on oxidative stress and inflammation in adenine-induced chronic renal failure in rats. PLoS One. 2013;8(2):e55242. doi: 10.1371/journal.pone.0055242. Epub 2013 Feb 1.
- Derived from this study: PubMed 32328307Ali NE, Kaddam LA, Alkarib SY, Kaballo BG, Khalid SA, Higawee A, AbdElhabib A, AlaaAldeen A, Phillips AO, Saeed AM. Gum Arabic (Acacia Senegal) Augmented Total Antioxidant Capacity and Reduced C-Reactive Protein among Haemodialysis Patients in Phase II Trial. Int J Nephrol. 2020 Apr 9;2020:7214673. doi: 10.1155/2020/7214673. eCollection 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gum Arabic in people with End-Stage Renal Disease, run by Lamis Kaddam 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 1 inclusion and 4 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 11 Jul 2017. 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.
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?
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?
Change from baseline Tumor necrosis factor alpha (time frame: Baseline and after 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 NCT03214692, 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 11 Jul 2017.