Home » Trials » SLCTR/2019/001
Effects of Selenium and Zinc supplementation in the progression of chronic kidney disease of uncertain etiology in Sri Lanka: Pilot single blinded randomized controlled trial
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SLCTR Registration Number
SLCTR/2019/001
Date of Registration
The date of last modification
Oct 14, 2019
Scientific Title of Trial
Effects of Selenium and Zinc supplementation in the progression of chronic kidney disease of uncertain etiology in Sri Lanka: Pilot single blinded randomized controlled trial
Public Title of Trial
Zinc and Selenium supplementation in patients with CKDu.
Disease or Health Condition(s) Studied
Chronic kidney disease of uncertain etiology in Sri Lanka.
Scientific Acronym
ZiSCKDu-P Trial
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1226-0963
Any other number(s) assigned to the trial and issuing authority
P/158/08/2018 (ERC: Kelaniya)
What is the research question being addressed?
Does Zinc and Selenium supplementation retard the progression of CKDu?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Data analysts, Outcome assessors
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
Randomization - Simple randomization without replacement.
There will be four arms of the study. Control group will receive a starch tablet as placebo. In the three groups of intervention, 1st will receive 60mg of Zinc Gluconate, 2nd will receive 200mcg of Selenium, 3rd will receive 60mg of Zinc Gluconate and 200mcg of Selenium. Duration of the intervention will be 90 days. Standard care will be delivered to all participants during the study period.
Following groups will be blinded: participants, data collectors, outcome adjudicators, data analysts. (health care providers will not be blinded)
Inclusion criteria
• Age 18-60 years
• Able to provide informed consent and willing to complete the follow-up visit
• Estimated glomerular filtration rate between 30 and 60 ml/min/1.73m2
• Suffering from CKDu (ie other identifiable causes of CKD excluded)
Exclusion criteria
• History of allergy to Zinc or Selenium
• Hemodialysis or peritoneal dialysis currently or within six months of recruitment
• Renal transplant recipient
• Pregnancy
• Breast feeding
Primary outcome(s)
|
1.
Rate of change in eGFR and change of urine albumin/ creatinine ratio between baseline and final follow-up. eGFR will be calculated from serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. |
[ At the completion of three months. ] |
Secondary outcome(s)
|
1.
Changes in body mass index, blood pressure and hemoglobin. |
[ At the completion of three months. ] |
Target number/sample size
60 (15 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2019-01-01
Anticipated end date
2019-06-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2018-10-16
Approval number
P/158/08/2018
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Prabath K Abeysundara
Senior Registrar in Internal Medicine
University Medical Unit, Colombo North Teaching Hospital, Ragama
Sri Lanka
Tel: +94112953409
Mob: +94718552918
heshanprabathkularathne@yahoo.com
Contact Person for Public Queries
Dr. Shamila T De Silva
Senior Lecturer
Department of Medicine, University of Kelaniya
Sri Lanka
Tel: +94112953409
Mob: +94773601490
shamiladp@hotmail.com
Primary study sponsor/organization
Department of Medicine, Faculty of Medicine
University of Kelaniya
Ragama,
Sri Lanka
Tel: +9411296100, +94 11 2953409
Fax: +94112958337
http://medicine.kln.ac.lk/depts/medicine/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
All individual participant data collected during the trial, after de-identification will be shared by the investigators. Additional documents such as the study protocol, statistical analysis plan and analytic code will be shared, immediately following publication with no end date. Data will be available to anyone who wishes to access the data, to achieve the aims in an approved proposal and for individual participant data meta analysis. Data will be available indefinitely at https://www.synapse.org/#!Profile:3386043/projects
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
