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A small scale preliminary study aimed at assessing the effects of different quantity (normal, low and very low protein diet supplemented with essential keto amino acids) of protein intakes on kidney Disease progression and the impact of this intervention in Quality of life of patients

Nutritional Intervention assessing the effects of varying protein intakes on Disease progression and Quality of life (QOL) in Chronic Kidney Disease (CKD): a PILOT Study - Dietary intervention in CKD prevention

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025785
Enrollment
130
Registered
2020-06-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate) Health Condition 2: N184- Chronic kidney disease, stage 4 (severe) Health Condition 3: N185- Chronic kidney disease, stage 5

Interventions

Intervention1: 3 different protein regime in 3 stages of Chronic kidney disease (Stage 3, 4 and 5 not on dialysis): Normal (0.8-1 gm/kg/day), a low protein diet (0.6gm/kg/day), or a very low protein d

Sponsors

Indian council of Medical research ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed as CKD Stages 3, 4 and 5 not on dialysis based on the KDIGO 2012 guidelines

Exclusion criteria

Exclusion criteria: 1. Any acute medical illness 2. Unstable renal function 3. Neurological illness, which causes hindrance in daily routine 4. Acute Kidney Injury 5. Renal Transplant Recipients 6. Malignancy 7. Pregnancy 8. Steroids Intake 9. Hypercalcemia (serum Calcium >10.5 mg/dl) 10. Alcoholics

Design outcomes

Primary

MeasureTime frame
Effect on different protein diet on prevention of CKD progression, delaying dialysis initiation, effect on nutrition, Quality of lifeTimepoint: 3 years—

Secondary

MeasureTime frame
Cost effectiveness of providing ketoanalogues (with VLPD) in relation to delay in initiation of dialysisTimepoint: 3 years—

Countries

India

Contacts

Public ContactHimansu Sekhar Mahapatra

ABVIMS Dr RML Hospital New Delhi

hsmnephro@gmail.com9968474805

Outcome results

None listed

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