Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Gum Arabic Supplementation in Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03789708
Recruitment Status : Active, not recruiting
First Posted : December 31, 2018
Last Update Posted : January 3, 2019
Sponsor:
Collaborators:
National Center for Kidney Diseases and Surgery
Almughtaribeen University
Information provided by (Responsible Party):
Sarra Elamin, University of Khartoum

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.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Dietary Supplement: Gum Arabic Other: Placebo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized and controlled clinical trial with parallel design
Masking: Double (Participant, Care Provider)
Masking Description: The placebo and the Gum Arabic are provided to patients in similar unlabeled packages
Primary Purpose: Treatment
Official Title: Study of Some Pharmacological and Biochemical Effects of Gum Arabic Supplementation to Hemodilaysis Patients
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : June 1, 2019

Arm Intervention/treatment
Experimental: A
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.
Dietary Supplement: Gum Arabic
Instantly soluble granules of Gum Arabic; 100% Acacia Senegal

Placebo Comparator: B
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.
Other: Placebo
Maltodextrin powder, easily soluble

Experimental: C
Patients will receive 20 g of Gum Arabic supplementation daily for four weeks
Dietary Supplement: Gum Arabic
Instantly soluble granules of Gum Arabic; 100% Acacia Senegal

Experimental: D
Patients will receive 40 g of Gum Arabic supplementation daily for four weeks
Dietary Supplement: Gum Arabic
Instantly soluble granules of Gum Arabic; 100% Acacia Senegal




Primary Outcome Measures :
  1. Highly sensitive C-reactive protein (hs CRP) level [ Time Frame: 4 weeks ]
    Change in serum level of highly sensitive C-reactive protein.

  2. Total anti-oxidant capacity [ Time Frame: 4 weeks ]
    Change in serum total anti-oxidant capacity

  3. Blood urea level [ Time Frame: 4 weeks ]
    Change in urea blood level


Secondary Outcome Measures :
  1. Serum calcium [ Time Frame: 4 weeks ]
    Change in serum calcium level

  2. Serum phosphorus [ Time Frame: 4 weeks ]
    Change in serum phosphorus level

  3. Serum uric acid [ Time Frame: 4 weeks ]
    Change in serum uric acid level



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789708


Locations
Layout table for location information
Sudan
Doctor Salma Center for Kidney Diseases
Khartoum, Sudan, 11111
Sponsors and Collaborators
University of Khartoum
National Center for Kidney Diseases and Surgery
Almughtaribeen University
Investigators
Layout table for investigator information
Principal Investigator: Sarra Elamin, MD Consultant Nephrologist

Layout table for additonal information
Responsible Party: Sarra Elamin, Assistant Professor, University of Khartoum
ClinicalTrials.gov Identifier: NCT03789708     History of Changes
Other Study ID Numbers: 016227
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic