The Effect of Renastart Formula Supplementation in Children With Acute Kidney Injury in Maintaining Normal Serum Electrolytes Levels

The Effect of Renastart Formula Supplementation on Serum Electrolytes in Children With Acute Kidney Injury

This clinical trial will evaluate Renastart formula effectiveness in children with acute kidney injury (AKI) and acute on top of chronic kidney disease (CKD), in maintaining normal serum electrolytes levels without using electrolyte binders,24 patients will be recruited from Pediatric Nephrology Unit (PNU), Children's Hospital, Ain Shams University, they will be assigned randomly in to two arms, arm 1 including patients who will be treated by electrolytes binders, arm 2 including patients who will be treated by Renastart formula, after initial assessment serum electrolyte evaluation will be followed up monthly for 3 months.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Drug: calcium carbonate (phosphorus binder) with / or sodium polystyrene sulfonate (potassium binder) with dosage 0.5-1mg/kg/day orally.; Dietary supplement: Renastart formula

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt, 1181
      • Faculty of Medicine-Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

•Infants and Children with AKI and acute on top of CKD Suffering from hyperkalemia and/or hyperphosphatemia at Pediatric Nephrology Unit (PNU), Children's Hospital, Ain Shams University Hospitals.

Exclusion Criteria:

• Patients are on dialysis.
• Pediatric patients with coexisting another medical problems and different risk factors which can affect serum electrolytes such as: Constipation, high volume blood transfusion and Diabetes medications disrupt potassium balance e.g., ACEI, ARBS and Diuretics.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1 patients with AKI and acute on top of CKD who will be treated by electrolytes binders.; they will start calcium carbonate (phosphorus binder) with dosage 45-65 mg/kg/day orally with / or sodium polystyrene sulfonate (potassium binder) with dosage 0.5-1mg/kg/day orally.	Drug: calcium carbonate (phosphorus binder) with / or sodium polystyrene sulfonate (potassium binder) with dosage 0.5-1mg/kg/day orally.; calcium carbonate (phosphorus binder) in dosage of 45-65 mg/kg/day orally with / or sodium polystyrene sulfonate (potassium binder) in dosage of 0.5-1mg/kg/day orally.
Experimental: Arm 2 patients with AKI and acute on top of CKD who will be treated by Renastart formula.; Renastart formula will be used with breast milk, standard infant formula or with diet.; Preparation: Adding one level scoop of Renastart to 30 ml water.; Renastart formula will be started to represent ¼ recommended daily allowance of daily caloric intake and the dose will be adjusted according to serum electrolyte levels.	Dietary supplement: Renastart formula; Renastart formula is an artificial formula is made by Vitaflo USA, Nestle Health Science Company.; Renastart formula preparation: Adding one level scoop of Renastart to 30 ml water.; Renastart formula will be used with breast milk, standard infant formula, standard pediatric infant feed and/ or mixed with diet.; Renastart formula dosage will be adjusted to be 1/4 Renastart and 3/4 breast milk, standard infant formula or standard pediatric infant daily caloric feed ratio.; Readjusting dosage ratio according to serum electrolytes levels especially potassium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the effectiveness and tolerability of Renastart formula in children with AKI and acute on top of CKD to correct and maintain normal serum levels of electrolytes.	serum electrolytes	monthly for 3 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Haya E Ibrahim, MD, lecturer of pediatrics,Faculty of Medicine, Ain shams University

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2022
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Wounds and Injuries; Acute Kidney Injury; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Calcium-Regulating Hormones and Agents; Chelating Agents; Sequestering Agents; Antacids; Calcium; Calcium Carbonate; Polystyrene sulfonic acid
• Other Study ID Numbers: FMASU MS 643/ 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No