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Evaluation of the effect of RenaStart formula in children with chronic kidney disease

Effect of RenaStart in Improving Biochemical status of potassium and phosphorus in children with chronic kidney diseases

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251122068075N1
Enrollment
40
Registered
2025-12-17
Start date
2025-12-22
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

chronic kidney diseases, End stage kidney disease. Chronic kidney disease, stage 3 (moderate)

Interventions

Intervention 1: Intervention Group: Children with stage 3 or higher chronic kidney disease receive RenaStart nutritional formula. The dosage is individually adjusted based on age, disease stage, and s

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Months to 18 Years

Inclusion criteria

Inclusion criteria: Willingness to voluntarily participate in the study A confirmed diagnosis of Chronic Kidney Disease (CKD) by the treating physician, at Stage 3 or higher Age 18 years or younger at the time of enrollment. (The age groups of birth to 10 years and 10 to 18 years will be evaluated separately)

Exclusion criteria

Exclusion criteria: Patients who receive Total Parenteral Nutrition (TPN) Patients with confirmed intolerance or allergy to cow's milk or any component of Renastart. Medical condition: Malabsorption disorders.Hepatic failure, Hemodynamic instability, Sepsis and other confirmed active infections. Concurrent participation in another clinical trial.

Design outcomes

Primary

MeasureTime frame
Potassium Serum Level. Timepoint: at first - End of the first month, End of the second month, End of the third month. Method of measurement: Flame Photometry for measuring serum potassium levels and standard.;Phosphorus Serum Level. Timepoint: at first - End of the first month, End of the second month, End of the third. Method of measurement: Phosphorus analysis method by UV spectrophotometry.

Secondary

MeasureTime frame
Serum calcium level as an indicator of mineral balance during nutritional intervention. Timepoint: At baseline, end of month 1, end of month 3, and end of the study. Method of measurement: Laboratory biochemical analysis (serum calcium).;Serum sodium concentration. Timepoint: Baseline, end of month 1, end of month 3, and end of study. Method of measurement: Biochemical laboratory measurement.;Serum creatinine level. Timepoint: Baseline, end of month 1, end of month 3, and end of study. Method of measurement: Measured using standard clinical chemistry assays.;Serum albumin level. Timepoint: Baseline, end of month 1, end of month 3, and end of study. Method of measurement: Measured by routine biochemical laboratory tests.;Body weight (kg). Timepoint: Baseline, end of month 1, end of month 3, and end of study. Method of measurement: Measured using a calibrated digital scale.;Body height (cm). Timepoint: Baseline, end of month 1, end of month 3, and end of study. Method of measurement: Measured using a stadiometer.;Mid-upper arm circumference. Timepoint: Baseline, end of month 1, end of month 3, and end of study. Method of measurement: Measured using a non-stretch measuring tape.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Khazdouz

Iran University of Medical Sciences

maryam.khazdouz@hotmail.com+98 21 2304 6387

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026