Study to Assess the Efficacy and Safety of Oral Potassium Citrate on the Prevention of Nephrocalcinosis in Extreme Premature

Phase 3

• Conditions: Nephrocalcinosis
• Interventions: Drug: Placebo; Drug: Potassium Citrate

• Registration Number: NCT01756547
• Lead Sponsor: Juan A. Arnaiz

Brief Summary

Study to assess the efficacy and safety of oral potassium citrate on the Prevention of nephrocalcinosis in extreme premature: a clinical trial, randomized, double-blind placebo controlled trial.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-12
• Study First Submitted: 2012-12-20
• Study First Submitted QC: 2012-12-26
• Last Update Submitted: 2012-12-26
• Study First Posted: 2012-12-27
• Last Update Posted: 2012-12-27
• Study Start: 2013-01
• Primary Completion: 2013-12
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

1. Premature infants of both sexes born at the Hospital Clinic of Barcelona.
2. Corrected gestational age below 32 weeks and lower birth weight 1500gr.
3. Survivors at 7 days old.
4. Clinically stable, in the opinion of the investigator, at the time of inclusion.
5. That, properly informed, parents and / or legal guardians give written consent to allow the participation of the infant in the study and submit to the tests and examinations that it entails

Exclusion Criteria

1. Renal malformations, cardiac or gastrointestinal prenatal or postnatal diagnosis.
2. Chronic renal failure (serum creatinine> 1.5 mg / dL or an increase of 0.3 mg / dL / day and / or oliguria defined as diuresis <0.5 mL / kg / hour after the first day of life)
3. Treatment with furosemide or dexamethasone
4. Addison's disease.
5. Persistent severe metabolic alkalosis.
6. Impossibility of oral feeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Oral solution 30ml, that contains distilled water and simple syrup, in the same dose like the active treatment 0,3ml/kg/day.
Potassium citrate	Potassium Citrate	Potassium citrate, oral solution contains Tripotassium citrate monohydrate 20 grams, Citric acid monohydrate 4 grams, distilled water 40 ml, and simple syrup 100ml. The solution contained in a bottle of glass that contains 20 ml of 2 meq/ml of potassium and 2.5 meq/ml of citrate. The dose is 0,3ml/kg/day of the solution until the 38-40 weeks of corrected gestational age.

Primary Outcome Measures

Name	Time	Method
incidence of nephrocalcinosis in extremely preterm infants	38-40 weeks of corrected gestational age	incidence of nephrocalcinosis in extremely preterm infants

Secondary Outcome Measures

Name	Time	Method
To determine the incidence of adverse events and serious adverse events related to study treatment.	38-40 weeks of corrected gestational age	To determine the incidence of adverse events and serious adverse events related to study treatment.
Determine whether the administration of potassium citrate in extreme premature decreases neonates the levels of calcium and calcium / creatinine ratio in urine in each of the branches of treatment at 38-40 weeks	38-40 weeks of corrected gestational age	Determine whether the administration of potassium citrate in extreme premature decreases neonates the levels of calcium and calcium / creatinine ratio in urine in each of the branches of treatment at 38-40 weeks
To determine whether administration of potassium citrate improves the levels of urinary phosphorus, potassium, sodium, citrate, creatinine, oxalate, ratio citrate / calcium , and ph value	38-40 weeks of corrected gestational age	To determine whether administration of potassium citrate in extreme premature infants improves the levels of phosphorus, potassium, sodium, citrate, creatinine, oxalate, and ratio citrate / calcium and ph in urine in each treatment arm at the 38-40 weeks.
Determine whether the administration of potassium citrate improves the plasma levels of sodium, potassium, creatinine, calcium, and ph value.	38-40 weeks of corrected gestational age	Determine whether the administration of potassium citrate in extreme premature neonates improves the plasma levels of sodium, potassium, creatinine, calcium, and blood ph value in each of the branches of treatment at 38-40 weeks.

Trial Locations

Locations (1)

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain