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Oxidative stress in Chronic Kidney Disease of unknown aetiology (CKDu) and the efficacy and safety of vitamin C and vitamin E in slowing the progression of early stages of CKDu in Sri Lanka. – A Double Blinded Placebo Controlled Randomized Clinical Trial -

SLCTR Registration Number

SLCTR/2018/030


Date of Registration

10 Sep 2018

The date of last modification

Nov 13, 2018



Application Summary


Scientific Title of Trial

Oxidative stress in Chronic Kidney Disease of unknown aetiology (CKDu) and the efficacy and safety of vitamin C and vitamin E in slowing the progression of early stages of CKDu in Sri Lanka. – A Double Blinded Placebo Controlled Randomized Clinical Trial


Public Title of Trial

Oxidative stress in Chronic Kidney Disease of unknown aetiology (CKDu) and the efficacy and safety of vitamin C and vitamin E in slowing the progression of early stages of CKDu in Sri Lanka


Disease of Health Condition(s) Studied

Chronic Kidney Disease of Unknown Etiology


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1204-3986


Any other number(s) assigned to the trial and issuing authority

EC/16/185 (ERC: Faculty of Medicine, Colombo)


Trial Details


What is the research question being addressed?

What is the efficacy and safety of the antioxidants vitamin C and vitamin E in preventing the progression of early stages of CKDu?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded


Control

Placebo


Assignment

Parallel


Purpose

Treatment


Purpose

Phase 3


Intervention(s) planned

Study setting: University Medical Unit at Teaching Hospital, Anuradhapura.

Participants meeting the inclusion/exclusion criteria will be allocated to the study arm using the computer-generated randomization, in a ratio of 2:1 (intervention: control).

Arm 1 (intervention arm): The treatment group will receive oral Vitamin C 200mg and oral Vitamin E 400mg to be taken daily for a period of one year.

Arm 2 (control arm): The placebo group will receive tablets and capsules similar in appearance and flavor to the treatment group to be taken orally, daily for a period of one year. The matching placebo for the vitamin C preparation will contain lactose monohydrate and magnesium stearate, and the matching placebo for the vitamin E will contain lactose monohydrate and stearic acid.

All the drugs and placebos will be sealed in sequentially numbered identical envelopes according to the allocation sequence.

All patients will be followed up once in every 2 months at the clinic to assess their compliance with medications, side effects, diet and any other medical complaints.

The following persons will be blinded to the intervention status: participants, healthcare providers, data collectors, outcome assessors, data analysts.


Inclusion criteria

  1. Male and female patients aged between 18 and 45 years
  2. Diagnosed with stages 1-3 of chronic kidney disease of unknown origin, as determined by
    • Albuminuria (ACR >30 mg/g)
    • Decreased GFR
    • Lower serum levels of liver enzymes
    • Increased Beta-2 microglobulin (B2M) concentration
    • Low serum bilirubin level

Exclusion criteria

  1. Patients with renal insufficiency with a potentially reversible cause such as: malignant hypertension, urinary tract infection, hypercalcemia, drug-induced nephrotoxic effects systemic diseases such as connective-tissue diseases.
  2. Patients on drugs which are known to be used as antioxidants, such as Coenzyme Q10 (ubiquinone), Fish Oil (Omega – 3 polyunsaturated fatty acids), Vitamin B complex 100, Vitamin B12, Vitamin D3, Vitamin C, Vitamin E.
  3. Patients with Acute myocardial infarction or cerebrovascular accident in the previous 6 months.
  4. Patients with chronic diseases (e.g. bronchial asthma and chronic liver cell disease).
  5. Drug or alcohol abused Patients.
  6. Patients who are pregnant or breastfeeding.
  7. Patients who are not willing to participate in the study.
  8. Patients with Drug allergies.
  9. Patients with CKDu in stage 4 & 5.


Primary outcome(s)

Change in oxidative stress as determined by

  1. Total Glutathione level in RBCs (Glutathione Assay Kit)

  2. Serum protein carbonyl levels (Protein Carbonyl Content Kit)

  3. Serum lipid peroxide levels (Absorbance of sample supernatant will be measured using a spectrophotometer and the level will be extrapolated using the standard curve of H2O2 concentrations)

  4. Serum anti-oxidant capacity (Absorbance were measured using a spectrophotometer and serum Trolox equivalent antioxidant capacity will calculate using the Trolox standard curve.)


Primary outcome(s) - Time of assessment(s)

At baseline and then every 4 months until the end of 1 year from the commencement of the intervention.


Secondary outcome

Change in the rate of progression of CKDu as determined by

  1. Concentration of beta 2 microglobulin /creatinine and the proportion it has decreased or increased during the time period (measured by using beta 2 microglobulin / creatinine ratio in a spot sample of urine)

  2. Improvement or slower rate of decrease in eGFR (calculated using the CKD-EPI equation)

  3. Reduction or slower progression of renal damage detected by Albumin Creatinine Ratio (ACR), ((measured in a spot sample of urine)


Secondary outcome(s) - Time of assessment(s)

At baseline and then every 4 months until the end of 1 year from the commencement of the intervention.



Target number/sample size

125 (82 in the treatment arm & 43 in the control arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2018-10-10


Anticipated end date

2021-10-20


Recruitment status

Pending


State of ethics review approval

Approved by the Ethical Review Committee of Faculty of Medicine, University of Colombo on 21st September 2017 (Ref. EC-16-185)


Funding source

University of Colombo (Grant No: AP/3/2/2016/CG/25)



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Prof. Saroj Jayasinghe
Professor of Medicine
Department of Clinical Medicine, Faculty of Medicine, University of Colombo, No. 25, Kynsey Road, Colombo 08, Sri Lanka
Tel: +94 - 11 – 2695300
Mob: +94 - 71 - 8619331

sarojoffice@yahoo.com

Contact Person for Public Queries

Ms. Chathuri Rodrigo
Research Assistant
Department of Clinical Medicine, Faculty of Medicine, University of Colombo, No. 25, Kynsey Road, Colombo 08, Sri Lanka

Mob: +94 - 71 - 9210016

chathuri.cmb.ckdu@gmail.com


Primary study sponsor/organization

University of Colombo, Sri Lanka

Academic & Publication Branch College House, No 94, Kumarathunga Munidasa Mawatha, Colombo 3, Sri Lanka
Tel: 0112586712
Fax: 0112586712
acpbuoc@gmail.com
http://www.cmb.ac.lk/administration/?page_id=155

Secondary study sponsor (If any)

None