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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in Sudan

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.

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 groups in NCT03214692
Study groupRoleWhat they receive
Gum ArabicExperimentalThe 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.

  1. Change from baseline Tumor necrosis factor alpha

    pg/mL

    Measured: Baseline and after 12 weeks

  2. Change from baseline Oxidative stress marker malondialdehyde

    nmol/mL

    Measured: Baseline and after 12 weeks

Secondary outcomes (1)
  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.

  1. First posted11 Jul 2017
  2. Study startJul 2017 (estimated)
  3. Primary completionOct 2017 (estimated)
  4. Study completionOct 2017 (estimated)

Resources

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)
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 28331623
  • Ali 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 23383316
  • Ali 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

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.

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