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

NCT06218212 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-02-05

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Haya E Ibrahim, MD · lecturer of pediatrics,Faculty of Medicine, Ain shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-12
Primary Completion
2023-03-30
Completion
2023-06-30

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06218212 on ClinicalTrials.gov