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

01 Jan 2019

The date of last modification

Mar 03, 2019



Application Summary


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)


Trial Details


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

  1. Study setting - Nephrology clinic, District General Hospital, Polonnaruwa
  2. Randomization - Simple randomization without replacement.

  3. 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.

  4. 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



State of Ethics Review Approval


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 & Sponsor Information


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/

Secondary study sponsor (If any)

None





Trial Completion details


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