SLCTR/2018/030
Not yet recruiting
Phase 3
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
niversity of Colombo, Sri Lanka0 sitesTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Chronic Kidney Disease of Unknown Etiology
- Sponsor
- niversity of Colombo, Sri Lanka
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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\.
Outcomes
Primary Outcomes
Not specified
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