About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
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.
Able and willing to complete the whole period of the study (maximum of 266 days from enrolment).
Disqualifiers
Women of childbearing potential not adopting any methods of contraception, have not undergone sterilization.
Women Pregnant or lactating
Patients who plan to conceive (or for their partners to conceive) within 12 months of randomization.
Patient presenting with serum K+levels ≥ 6mmol/L based on the last two reports as per medical records.
Trial design
Crossover
Treatments tested in this trial
Gum Arabic
Dietary supplementGum Arabic (Acacia seyal and Acacia senegal) 30g powdered GA in 100ml water, consumed daily.
Water
Other intervention100ml water, consumed daily
Treatment groups
Trial outcomes
Primary outcomes
Change in mean average clearance of urea and creatinine in a full 24-hour urine collection.
To evaluate the effect of Gum Arabic (GA) on residual renal function in end stage renal disease (ESRD) patients on dialysis as measured by the achievement of at least 5 millilitres/minute improvement in mean average urea creatinine clearance.
Secondary outcomes
Changes in urine volume
Evaluate changes in urine volume collected for 24 hours over long intradialytic period (ml)
Changes in serum lipids
Evaluate changes in serum cholesterol (mmol/l)
Changes in intradialytic weight gain.
Evaluate changes in intradialytic weight gain (kg)
Side effects bad enough to discontinue IP
Percentage of patients who have side effects that cause them to discontinue therapy.(%)
Other outcomes
Exploratory end point
Analyze impacts on cardiac health ECG changes
Exploratory end point
Analyze impacts Fructosamines (mmol/l)
Sponsors and contacts
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