The Effect of Gum Arabic (GA) on Residual Renal Function in Adult Dialysis Patients in Abu Dhabi

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbu Dhabi Health Services Company

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Gum Arabic

    Dietary supplement

    Gum Arabic (Acacia seyal and Acacia senegal) 30g powdered GA in 100ml water, consumed daily.

  • Water

    Other intervention

    100ml water, consumed daily

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Treatment A: 30g powdered GA in 100ml water, consumed dailyExperimental treatment 1 intervention
Group B: Treatment B: 100ml water, consumed daily.Other 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months

Secondary outcomes

1

Changes in urine volume

Evaluate changes in urine volume collected for 24 hours over long intradialytic period (ml)

Time frame
3 months
2

Changes in serum lipids

Evaluate changes in serum cholesterol (mmol/l)

Time frame
3 months
3

Changes in intradialytic weight gain.

Evaluate changes in intradialytic weight gain (kg)

Time frame
3 months
4

Side effects bad enough to discontinue IP

Percentage of patients who have side effects that cause them to discontinue therapy.(%)

Time frame
3 months

Other outcomes

1

Exploratory end point

Analyze impacts on cardiac health ECG changes

Time frame
3 months
2

Exploratory end point

Analyze impacts Fructosamines (mmol/l)

Time frame
3 months

Sponsors and contacts

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