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Effects of Gum Arabic Supplementation in Hemodialysis Patients

Primary Purpose

Kidney Failure, Chronic

Status
Unknown status
Phase
Not Applicable
Locations
Sudan
Study Type
Interventional
Intervention
Gum Arabic
Placebo
Sponsored by
University of Khartoum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult end-stage renal disease patients maintained on regular hemodialysis

Exclusion Criteria:

  • Chronic liver disease
  • Malignant condition
  • Inflammatory bowel disease
  • History of bowel resection
  • Long term antibiotic therapy
  • Pregnancy or lactation
  • Current use of immunosuppressive medication

Sites / Locations

  • Doctor Salma Center for Kidney Diseases

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

A

B

C

D

Arm Description

Patients will receive 10 g of Gum Arabic supplementation daily for four weeks. Gum Arabic is provided in the form of easily soluble granules. Participants are asked to dissolve it in water or juice and drink it.

Patients will receive 5 g of maltodextrin supplementation daily for four weeks. Maltodextrin is an easily digested polysacharide provided in the form of soluble whitish powder that has no taste or odor. Participants are asked to dissolve it in water or juice and drink it.

Patients will receive 20 g of Gum Arabic supplementation daily for four weeks

Patients will receive 40 g of Gum Arabic supplementation daily for four weeks

Outcomes

Primary Outcome Measures

Highly sensitive C-reactive protein (hs CRP) level
Change in serum level of highly sensitive C-reactive protein.
Total anti-oxidant capacity
Change in serum total anti-oxidant capacity
Blood urea level
Change in urea blood level

Secondary Outcome Measures

Serum calcium
Change in serum calcium level
Serum phosphorus
Change in serum phosphorus level
Serum uric acid
Change in serum uric acid level

Full Information

First Posted
December 27, 2018
Last Updated
December 31, 2018
Sponsor
University of Khartoum
Collaborators
National Center for Kidney Diseases and Surgery, Almughtaribeen University
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1. Study Identification

Unique Protocol Identification Number
NCT03789708
Brief Title
Effects of Gum Arabic Supplementation in Hemodialysis Patients
Official Title
Study of Some Pharmacological and Biochemical Effects of Gum Arabic Supplementation to Hemodilaysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Anticipated)
Study Completion Date
June 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Khartoum
Collaborators
National Center for Kidney Diseases and Surgery, Almughtaribeen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Gum Arabic is a naturally produced gummy exudate from Acacia Senegal tree. It's a complex polysaccharide with proven prebiotic properties. Through its effect on intestinal bacteria, it's expected to reduce systemic levels of toxic bacterial metabolites and reduce inflammatory markers.By increasing fecal bacteria mass it's also expected to reduce blood urea level. These changes are potentially beneficial to hemodialysis patients who suffer from disturbed intestinal flora and a chronic inflammatory status. The investigators hypothesize that supplementing the diet of hemodialysis patients with Gum Arabic for four weeks would reduce inflammatory markers, increase total anti-oxidant capacity and reduce blood urea concentration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized and controlled clinical trial with parallel design
Masking
ParticipantCare Provider
Masking Description
The placebo and the Gum Arabic are provided to patients in similar unlabeled packages
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Patients will receive 10 g of Gum Arabic supplementation daily for four weeks. Gum Arabic is provided in the form of easily soluble granules. Participants are asked to dissolve it in water or juice and drink it.
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Patients will receive 5 g of maltodextrin supplementation daily for four weeks. Maltodextrin is an easily digested polysacharide provided in the form of soluble whitish powder that has no taste or odor. Participants are asked to dissolve it in water or juice and drink it.
Arm Title
C
Arm Type
Experimental
Arm Description
Patients will receive 20 g of Gum Arabic supplementation daily for four weeks
Arm Title
D
Arm Type
Experimental
Arm Description
Patients will receive 40 g of Gum Arabic supplementation daily for four weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Gum Arabic
Intervention Description
Instantly soluble granules of Gum Arabic; 100% Acacia Senegal
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Maltodextrin powder, easily soluble
Primary Outcome Measure Information:
Title
Highly sensitive C-reactive protein (hs CRP) level
Description
Change in serum level of highly sensitive C-reactive protein.
Time Frame
4 weeks
Title
Total anti-oxidant capacity
Description
Change in serum total anti-oxidant capacity
Time Frame
4 weeks
Title
Blood urea level
Description
Change in urea blood level
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Serum calcium
Description
Change in serum calcium level
Time Frame
4 weeks
Title
Serum phosphorus
Description
Change in serum phosphorus level
Time Frame
4 weeks
Title
Serum uric acid
Description
Change in serum uric acid level
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult end-stage renal disease patients maintained on regular hemodialysis Exclusion Criteria: Chronic liver disease Malignant condition Inflammatory bowel disease History of bowel resection Long term antibiotic therapy Pregnancy or lactation Current use of immunosuppressive medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarra Elamin, MD
Organizational Affiliation
Consultant Nephrologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Doctor Salma Center for Kidney Diseases
City
Khartoum
ZIP/Postal Code
11111
Country
Sudan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effects of Gum Arabic Supplementation in Hemodialysis Patients

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