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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2018/030

Enrollment

Unknown

Registered

2018-09-10

Start date

2018-10-10

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease of Unknown Etiology

Interventions

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 random

Eligibility

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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.) [At baseline and then every 4 months until the end of 1 year from the commencement of the intervention.]	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
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) [At baseline and then every 4 months until the end of 1 year from the commencement of the intervention.]	—

Measure

Time frame

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

—

Countries

Sri Lanka

Contacts

Public ContactProf. Saroj Jayasinghe

Professor of Medicine

sarojoffice@yahoo.comTel: +94 - 11 – 2695300

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026