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Clinical trial

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

ID
Name
FMASU MS 643/ 2021
Description
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.
Trial arms
Trial start
2022-02-12
Estimated PCD
2023-03-30
Trial end
2023-06-30
Status
Completed
Treatment
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.
Arms:
Arm 2 patients with AKI and acute on top of CKD who will be treated by Renastart formula.
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.
Arms:
Arm 1 patients with AKI and acute on top of CKD who will be treated by electrolytes binders.
Size
24
Primary endpoint
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.
monthly for 3 months
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}
Updated at
2024-02-05

1 organization

1 product

1 indication

Organization
Ain Shams University
Product
Calcium Carbonate
Indication
Acute Kidney Injury