Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201510001123334 Date of Approval: 29/04/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Gum Arabic and Kidney Disease
Official scientific title Gum Arabic In Renal Disease Study (GARDS)
Brief summary describing the background and objectives of the trial Overview of The Trial A randomized controlled, two arm clinical trial to be conducted on chronic renal disease patients at or beyond CKD stage IIIb but who are not at the point of requiring dialysis, over a twelve months period. The Research Question: Does dietary supplementation with Gum Arabic have beneficial effects for patients with chronic renal disease? Aim of the Trial The present study is an attempt to find a complementary therapy for the chronic renal disease patients through scientific validation of a traditionally used remedy in Sudanese folk medicine. Objectives ¿ To conduct a well-designed multi-centered clinical trial to answer the research question by using a predetermined daily dose of Gum Arabic on selected chronic renal disease patients. ¿ To measure potential beneficial outcomes and provide potential mechanistic insight into the effect seen with the use of Gum Arabic on chronic renal disease patients. ¿ The direct beneficial parameters to be measured are: blood pressure, and renal function and indirect beneficial measures will be on the generation of uremic toxins and change in the colonic bacterial activity.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) GARDS
Disease(s) or condition(s) being studied Chronic Kidney Disease,Kidney Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 31/07/2015
Actual trial start date
Anticipated date of last follow up 01/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Computerised randomisation central randomisation Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dietary supplementation with Gum Arabic 25g daily increased at 6 months to 50g 12 months Dietary supplemetation 75
Control Group Dietary supplementation with Gum Arabic No supplementation for control group 12 months Routine standard clinical care 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Chronic renal disease patients with eGFR¿45ml/min (equating to ¿ CKD stage IIIb) Patient will have rate of progression of renal disease of >3ml/min/year but no more than 10ml/min/year Patient will not be at the point of requiring dialysis Pregnant women Volunteers under the age of 18yrs Patients with an acute ongoing illness 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/05/2014 Secretariat General National Medicines and Poison Board Republic of Sudan
Ethics Committee Address
Street address City Postal code Country
National Medicines and Poison Bord Republic of Sudan Khartoum 0000000 Sudan
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Rate of progession of renal disase 3 months 6 months 12 months 18 months (washout period)
Primary Outcome Blood Pressure Monthly throughout trial and wash out period
Secondary Outcome Serum uremic toxins baseline 6 months 12 months 15 months (washout)
Secondary Outcome Change in stool bacterial content baseline 3 months 6 months 12 months 15 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ibn Sina Medical Centre Khartoum Sudan
Ahmed Gasim Centre Khartoum North Sudan
Arif Military Hospital Omdurman Sudan
Dr Salma Medical Center Khartoum Sudan
FUNDING SOURCES
Name of source Street address City Postal code Country
Ministry of Science and Technology Government of Sudan Khartoum Sudan
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ministry of Science and Technology Government of Sudan Khartoum Sudan Funding Agency
Primary Sponsor Gum Arabic Board Sudan (GAB) Obaid Khatim St Khartoum Postal code 11123 Sudan Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Professor Aled Phillips Cardiff University School of Medicine Cardiff CF14 4 XN United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sami Khalid khalidseek@hotmail.com +249 (1) 83771 290 Faculty of Pharmacy, University of Science & Technology Omdurman, Althora mid street P.O.Box 477 Omdurman
City Postal code Country Position/Affiliation
Khartoum 11111 Sudan Faculty of Pharmacy University of Science & Technology
Role Name Email Phone Street address
Public Enquiries Sami A Khalid khalidseek@hotmail.com +249 9 12146087 Faculty of Pharmacy, University of Science & Technology
City Postal code Country Position/Affiliation
Omdurman 11111 Sudan Professor of Pharmacy
Role Name Email Phone Street address
Scientific Enquiries Aled Phillips Phillipsao@cf.ac.uk +442920748467 Cardiff University School of Medicine
City Postal code Country Position/Affiliation
Cardiff CF14 4XN United Kingdom Professor of Nephrology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information