NCT03214692

Brief Summary

Oxidative processes increased in patients with renal failure and especially patients with end stage renal failure on dialysis. Oxidative stress plays a role in renal damage and also on cardiovascular disease, atherosclerosis, which can accelerate renal damage. Gum Arabic is claimed to have antioxidant effect and this will decrease the harmful effect of the free radical on patient on hemodialysis. In this study investigators are aiming to see the effect of Gum Arabic on Oxidative Stress and inflammatory markers in patients on regular hemodialysis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

3 months

First QC Date

June 18, 2017

Last Update Submit

July 10, 2017

Conditions

End-Stage Renal Disease

Keywords

Gum ArabicRenal failureHemodialysisAntioxidant and anti-inflammatory

Outcome Measures

Primary Outcomes (2)

  • Change from baseline Tumor necrosis factor alpha

    pg/mL

    Baseline and after 12 weeks

  • Change from baseline Oxidative stress marker malondialdehyde

    nmol/mL

    Baseline and after 12 weeks

Secondary Outcomes (1)

  • Glomerular Filtration Rate (GFR)

    Baseline and every four weeks for 12 weeks

Study Arms (1)

Gum Arabic

EXPERIMENTAL

The patients will receive 30 grams of Gum Arabic dissolved in 200 ml of water to ingest orally

Dietary Supplement: Gum Arabic

Interventions

Gum ArabicDIETARY_SUPPLEMENT

Oral intake of GA in powder from30 grams per day

Gum Arabic

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • End stage renal disease patients on regular hemodialysis.

You may not qualify if:

  • Patient known have ischemic heart disease (coronary artery disease),
  • Pregnant women,
  • Patient who have impaired liver function or hepatitis VIRUS positive,
  • Patient who HIV positive and patient currently use of GUM Arabic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military Hospital AlshaheedArif renal center

Khartoum, Umdorman, 1121, Sudan

Location

Related Publications (3)

  • Kaddam L, Fadl-Elmula I, Eisawi OA, Abdelrazig HA, Salih MA, Lang F, Saeed AM. Gum Arabic as novel anti-oxidant agent in sickle cell anemia, phase II trial. BMC Hematol. 2017 Mar 16;17:4. doi: 10.1186/s12878-017-0075-y. eCollection 2017.

    PMID: 28331623RESULT

  • Ali BH, Al-Husseni I, Beegam S, Al-Shukaili A, Nemmar A, Schierling S, Queisser N, Schupp N. Effect of gum arabic on oxidative stress and inflammation in adenine-induced chronic renal failure in rats. PLoS One. 2013;8(2):e55242. doi: 10.1371/journal.pone.0055242. Epub 2013 Feb 1.

    PMID: 23383316RESULT

  • Ali NE, Kaddam LA, Alkarib SY, Kaballo BG, Khalid SA, Higawee A, AbdElhabib A, AlaaAldeen A, Phillips AO, Saeed AM. Gum Arabic (Acacia Senegal) Augmented Total Antioxidant Capacity and Reduced C-Reactive Protein among Haemodialysis Patients in Phase II Trial. Int J Nephrol. 2020 Apr 9;2020:7214673. doi: 10.1155/2020/7214673. eCollection 2020.

    PMID: 32328307DERIVED

MeSH Terms

Conditions

Kidney Failure, ChronicRenal Insufficiency

Interventions

Gum Arabic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Daily ingestion of Gum Arabic for 12 weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 18, 2017

First Posted

July 11, 2017

Study Start

July 1, 2017

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

July 11, 2017

Record last verified: 2017-07

Locations

SU(1)