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.: PACTR202202482995099 Date of Approval: 10/02/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Barley and CKD in children
Official scientific title EFFECT OF BARLEY EXTRACT ON RISK FACTORS AND PROGRESSION OF PEDIATRIC CHRONIC KIDNEY DISEASE
Brief summary describing the background and objectives of the trial Background and Rationale: Children with CKD experience a lifetime increase in mortality, morbidity, and a decrease in quality of life Barley components have favorable effects on gut microbiota, uremic toxins, inflammation, oxidative stress, and potential benefits on proteinuria, blood pressure, lipid profile, and vascular reactivity. These are all risk factors for CVD and CKD progression; so, the effect of barley supplementation on risk profile and progression of pediatric CKD may be plausible Objectives : The present study aims to characterize the effect of barley’s active ingredients on CKD’s risk factors and progression in pediatric patients
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Kidney Disease,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/11/2021
Actual trial start date 30/11/2021
Anticipated date of last follow up 01/11/2022
Actual Last follow-up date 01/11/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Not yet recruiting
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group barley extract We maintain a related ratio of powder to water similar to traditional use, which about 10 grams per 100mL, therefore we prepare the extract in same ratio 1:10 .So patients will receive 30ml daily of a final concentration of 10g/dL (equivalent of 3g dry extract) 6 months All patients will be randomized 1:1 by computer randomized sequence into two groups & will receive the standard care for CKD. Besides: Group A (the intervention group) will receive barley extract. Group B (the control group) will receive a placebo. We will follow both groups at 1;3;6 month interval by clinical and biochemical parameters 30
Control Group placebo 30 ml of sugary syrup 6 months we will be blind for which group will receive barley extract and which group will receive placebo 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age between 6 and 14 years 2. Chronic kidney disease (CKD) stage 3-4 of any etiology, with an estimated GFR of <60mL/min/1.73m2 by Schwartz formula 3. Urine output more than 1ml/kg/h to avoid any possibility of fluid overload by administering barley extract. 1- Unwilling to participate in the study. 2- Comorbid diseases unrelated to CKD include diabetes mellitus, structural heart disease, active liver disease, pancreatic insufficiency, or Celiac disease Child: 6 Year-12 Year 6 Year(s) 14 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 22/08/2021 REC Cairo university
Ethics Committee Address
Street address City Postal code Country
kasralainy street cairo 11625 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Progression of CKD through assessment of change in measured creatinine clearance over six months 1,3,6 month interval
Secondary Outcome Compliance, tolerability, and any clinical events - Blood pressure control - Growth and anthropometric parameters - Proteinuria, lipid profile, glucose, urea, creatinine, Ca, P, and ALP 1,3,6 month interval
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo university children hospitals Al-Saray Street, El Manial Cairo Cairo 11956 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
investigators 183 King Faisal St Cairo 11311 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor the investigators Al-Saray Street, El Manial Cairo 11956 Egypt Cairo 11956 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hafez Bazaraa hmbazaraa@kasralainy.edu.eg +201205307470 Al-Saray Street, El Manial
City Postal code Country Position/Affiliation
Cairo 11956 Egypt professor of pediatrics Kasr alainy medical school Cairo university
Role Name Email Phone Street address
Scientific Enquiries Meselhy ragab meselhyragab@cu.edu.eg 0223639307 Kasr El-Aini St., Cairo 11652, Egypt
City Postal code Country Position/Affiliation
Cairo 11652 Egypt Professor of Natural Products Chemistry
Role Name Email Phone Street address
Public Enquiries Fatma Atia fatma.atia@kasralainy.edu.eg +201205307470 kasralainy street
City Postal code Country Position/Affiliation
Cairo 11625 Egypt lecturer of pediatrics
Role Name Email Phone Street address
Scientific Enquiries Essam Abdelsattar essam.abdelsattar@pharma.cu.edu.eg 0020106547211 37
City Postal code Country Position/Affiliation
Cairo 11311 Egypt professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices Study Protocol data will be available once published anyone who wishes to acess the data once published can find it via a link we will provide it once we complete this trial
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information