Clinical trial NCT06836206: The Effect of Gum Arabic (GA) on Residual Renal Function in Adult Dialysis Patients in Abu Dhabi
Official title: The Effect of Gum Arabic (GA) on Adult Dialysis Patients in Abu Dhabi: A Prospective Randomized-controlled Trial (The GADAD Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: End Stage Renal Disease (ESRD)
Keywords: Gum Arabic
ESRD
Acacia seyal and Acacia senegal
Lead sponsor: Abu Dhabi Health Services Company
Sponsor class: OTHER_GOV
First posted: 2025-02-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Open-label, randomized, crossover trial

Intervention:

Treatment A: Gum Arabic (Acacia seyal and Acacia senegal) in 100ml water Treatment B: Water 100ml Patients will receive either treatment A or B for 3 months followed by a washout then the other arm of therapy. ie randomized to the treatment sequence AB or BA
Primary purpose: TREATMENT

Brief summary: Gum Arabic (GA), derived from Acacia trees, has shown potential benefits in metabolic, renal, and inflammatory conditions. This study explores the impact of GA on residual renal function in end-stage renal disease (ESRD) patients undergoing dialysis, as current evidence is limited.

Detailed description: Gum Arabic (GA) is an exudate with a gummy texture obtained from Acacia seyal and Acacia senegal. It is an arabinogalactan-protein complex and is composed of magnesium, calcium, and potassium salts of Arabic acid. GA is widely used in sub-Saharan African countries as a traditional remedy for many years. Ingestion of GA has been claimed to have beneficial effects in several health conditions like metabolic syndrome, renal failure, hypertension, gingivitis, anaemia, and hypercholesterolemia. Clinical trials conducted earlier have studied the effect of GA on metabolic disorders like type 2 diabetes mellitus, hyperlipidaemia, gastrointestinal health, oral health, renal diseases, and diseases like sickle cell anaemia and rheumatoid arthritis. A few studies have described GA to exhibit antioxidant properties, anti-inflammatory, probiotic, and antibacterial properties. GA has high fibre content causing satiety and is suggested as a good dietary fibre in patients with chronic kidney disease (CKD) based on its effect on various physiological and biochemical parameters.

The effect of GA on CKD patients has only been studied in a few publications. A study of patients undergoing regular haemodialysis showed supplementation of GA 50g/day along with low protein diet for 3 months resulted in a significant reduction in serum urea, creatinine, uric acid and phosphate levels and a significant increase in serum calcium levels. Another clinical trial conducted in Saudi Arabia among CKD patients showed that supplementing the diet with GA for four weeks significantly reduced C-reactive protein (CRP) levels however, four weeks supplementation did not show any effect on the serum urea and creatinine levels. Another study on forty ESRD patients on haemodialysis showed that GA supplementation of 30g/day for 12 weeks significantly improved Hb levels and augmented total antioxidant capacity whilst reducing CRP. A clinical trial conducted on patients with stage 2 or 3 CKD demonstrated that GA supplementation of 25g/day for a year was well tolerated and was associated with a slowing in the rate of decline of renal function as measured by eGFR. A single case study published in 2009 reported the postponement of dialysis for six years in a young girl with advanced CKD using GA 1-1.5 g/kg/day combined with traditional conservative (dietary and pharmacological) treatments . A systematic review on efficacy and safety of GA in patients with CKD suggested that GA supplementation may improve parameters like serum creatinine, urea, sodium, and potassium, but early-stage intervention and long duration of therapy were more likely to improve renal parameters.

GA is commonly used in the making of food products like puddings, frostings and candies . It has demulcent property for which it is used in medications and is generally recognized as safe by the US Food and Drug Administration. Earlier animal studies in toxicology have shown that there were no significant harmful effects observed on chronic intake of GA and no known teratogenic effects in animals .

There is a paucity of data on drug interactions, but studies have shown that concurrent use of oral GA and amoxicillin changed the pharmacokinetics resulting in a significant reduction in the absorption of amoxicillin leading to sub therapeutic plasma concentrations. A animal study on gastric ulcers demonstrated that GA administration potentiated the anti-ulcer effect of ranitidine.

Limited evidence supports the beneficial effects of oral GA on renal function, and there are no definitive studies demonstrating an improvement in residual renal function in ESRD patients undergoing haemodialysis.

This trial aims to assess the effect of GA on residual renal function in ESRD patients on dialysis.

Eligibility criteria: Inclusion Criteria:

To be eligible to participate in this trial, an individual must meet all the following criteria:

1. Men and women ≥18 years of age with diagnosed ESRD and prescribed regular dialysis at least once a week, weekly at least for past two weeks.
2. For past two weeks including women of childbearing potential who are currently adopting any method of contraception or have completed the family and undergone sterilization procedures and women of non-childbearing potential.
3. Patients with residual renal function - Patients who produce a minimum of 200 ml of urine during a full day of collection (A full day collection: the patient discards the first urine sample on the day of collection then collects all urine for the entire day and night and collects the first urine sample of the next day) r on a non-dialysis long break day.
4. Able and willing to complete the whole period of the study (maximum of 266 days from enrolment).
5. With the ability to understand the study procedures, the informed consent \& voluntarily sign an informed consent form and be able to comply with the requirements of the protocol.

Exclusion Criteria:

1. Women of childbearing potential not adopting any methods of contraception, have not undergone sterilization.
2. Women Pregnant or lactating
3. Patients who plan to conceive (or for their partners to conceive) within 12 months of randomization.
4. Patient presenting with serum K+levels ≥ 6mmol/L based on the last two reports as per medical records.
5. Patients who produce less than 200 ml of urine during 24 hours urine collection at baseline assessment.
6. Peritoneal dialysis.
7. Kidney transplant or booked for a live transplant within 259 days of randomization.
8. Patients gaining \>4 kg between dialysis sessions in the past 2 weeks.
9. People with known allergies to quillaja bark or similar tree bark.
10. Patients are already participating in another clinical trial (excluding COVID-19 vaccine or COVID-19 drug trials).
11. Patients on immunosuppression for kidney transplant.

Additional exclusion criteria for follow-up visits.

1. Patient informs of pregnancy.
2. Severe adverse reaction to the interventional product.

Primary outcomes:
measure: Change in mean average clearance of urea and creatinine in a full 24-hour urine collection.
timeFrame: 3 months
Secondary outcomes:
measure: Changes in urine volume
timeFrame: 3 months
measure: Changes in serum lipids
timeFrame: 3 months
measure: Changes in intradialytic weight gain.
timeFrame: 3 months
measure: Side effects bad enough to discontinue IP
timeFrame: 3 months
measure: Changes in serum potassium
timeFrame: 3 months
Other outcomes:
measure: Exploratory end point
timeFrame: 3 months
measure: Exploratory end point
timeFrame: 3 months
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: SEHA Kidney Care (SKC)
Study officials:
affiliation: Abu Dhabi Health Services Co. -SEHA
name: Stephen G Holt, MD
role: PRINCIPAL_INVESTIGATOR
References:
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