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

Ain Shams University

Status: Completed

Conditions: Acute Kidney Injury

Treatments: Dietary Supplement: Renastart formula; Drug: calcium carbonate (phosphorus binder) with / or sodium polystyrene sulfonate (potassium binder) with dosage 0.5-1mg/kg/day orally.

Study type: Interventional

Funder types: Other

Identifiers

NCT06218212

FMASU MS 643/ 2021

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 1 month to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Arm 1 patients with AKI and acute on top of CKD who will be treated by electrolytes binders.

Active Comparator group

Description:

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.

Treatment:

Drug: calcium carbonate (phosphorus binder) with / or sodium polystyrene sulfonate (potassium binder) with dosage 0.5-1mg/kg/day orally.

Arm 2 patients with AKI and acute on top of CKD who will be treated by Renastart formula.

Experimental group

Description:

* 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.

Treatment:

Dietary Supplement: Renastart formula