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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

Phase 3
Not yet recruiting
Conditions
Chronic Kidney Disease of Unknown Etiology
Registration Number
SLCTR/2018/030
Lead Sponsor
niversity of Colombo, Sri Lanka
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
Not specified
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

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