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PEDIATRIC CHRONIC KIDNEY DISEASE PROGRAM: study of metabolomics

PEDIATRIC CHRONIC KIDNEY DISEASE PROGRAM: IDENTIFICATION OF BIOMARKERS BY SERUM AND URINARY METABOLONOMICS FOR EARLY IDENTIFICATION OF PROGRESSION - CKD metabolomics

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/12/048044
Enrollment
100
Registered
2022-12-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: N189- Chronic kidney disease, unspecified

Interventions

None listed

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children of age 2-18 years with diagnosed chronic kidney disease (all stages of CKD). Attempt shall be made to include 50 children in early stages (1-3) and another 50 in late (4-5) stages of CKD. For controls: Healthy age and gender matched children attending outpatients for minor illnesses in a 2:1 ratio of cases and controls. A total of 50 controls shall be enrolled.

Exclusion criteria

Exclusion criteria: Patient presently having acute kidney injury, any bacterial infections or receiving any immunosuppressants, with structural heart disease or undergoing dialysis will be excluded.

Design outcomes

Primary

MeasureTime frame
-Levels of serum creatinine, Cystatin C, 25 hydroxy D, parathormone and FGF-23 at baseline and in serial estimations -Levels of urinary metabolites Isocitric acid, succinic acid, citric acid, 2oxaloglutarate, Cisaconitate, N-acetylalanine, N-acetylserine, N-acetylthreonine, N-acetyllysine, C glycosylytrptophan, Pseudouridine, O sulfotyrosine at baseline and in serial estimations. Timepoint: -Levels of serum creatinine, Cystatin C, 25 hydroxy D, parathormone and FGF-23 at baseline and in serial estimations -Levels of urinary metabolites Isocitric acid, succinic acid, citric acid, 2oxaloglutarate, Cisaconitate, N-acetylalanine, N-acetylserine, N-acetylthreonine, N-acetyllysine, C glycosylytrptophan, Pseudouridine, O sulfotyrosine at baseline and in serial estimations.

Secondary

MeasureTime frame
Estimation of GFR by serum creatinine, Cystatin-C and combined serum creatinine and cystatin-C based equations and comparison of annual of eGFR fall in different stages of CKD -Correlation of serum creatinine and cystatin -C based equations in different stages of chronic kidney disease. -Comparison of estimated GFR by serum creatinine and Cystatin-C based equations with measured GFR (24 hours urinary creatinine clearance). -Correlation of eGFR fall with quantification of proteinuria -Measurement of hemoglobin levels, venous blood gas analysis, Calcium, phosphate, SAP, PTH, 25 hydroxy D and fibroblast growth factor-23 (FGF-23) at baseline and serial estimations -Assessment of macronutrients (carbohydrates, fats and proteins) and micronutrients (Iron, calcium, phosphates, sodium and potassium) as assessed by 24 hour 3 dietary recalls (2 mideweek and 1 weekend) at baseline and every 6 months for next 2 years. Timepoint: Every 6 months for a period of 2 years

Countries

India

Contacts

Public ContactMukta Mantan

Maulana Azad Medical college

muktamantan@hotmail.com9968604315

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026