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

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

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.

Study Overview

• Status: Unknown
• Conditions: Nephrocalcinosis
• Intervention / Treatment: Drug: Placebo; Drug: Potassium Citrate

• Study Type: Interventional
• Enrollment (Anticipated): 74
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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 or unacceptable toxicity develops.
Placebo Comparator: Placebo; Oral solution 30ml, that contains distilled water and simple syrup, in the same dose like the active treatment 0,3ml/kg/day.	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of nephrocalcinosis in extremely preterm infants	incidence of nephrocalcinosis in extremely preterm infants	38-40 weeks of corrected gestational age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
To determine whether administration of potassium citrate improves the levels of urinary phosphorus, potassium, sodium, citrate, creatinine, oxalate, ratio citrate / calcium , and ph value	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.	38-40 weeks of corrected gestational age
Determine whether the administration of potassium citrate improves the plasma levels of sodium, potassium, creatinine, calcium, and ph value.	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.	38-40 weeks of corrected gestational age
To determine the incidence of adverse events and serious adverse events related to study treatment.	To determine the incidence of adverse events and serious adverse events related to study treatment.	38-40 weeks of corrected gestational age

Collaborators and Investigators

• Sponsor: Juan A. Arnaiz
• Investigators: Principal Investigator: Francisco Botet Mussons, MD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): January 1, 2014

Study Registration Dates

• First Submitted: December 20, 2012
• First Submitted That Met QC Criteria: December 26, 2012
• First Posted (Estimate): December 27, 2012

Study Record Updates

• Last Update Posted (Estimate): December 27, 2012
• Last Update Submitted That Met QC Criteria: December 26, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Nephrocalcinosis; Extreme premature
• Additional Relevant MeSH Terms: Metabolic Diseases; Kidney Diseases; Urologic Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Calcium Metabolism Disorders; Calcinosis; Premature Birth; Nephrocalcinosis; Physiological Effects of Drugs; Natriuretic Agents; Diuretics; Respiratory System Agents; Expectorants; Potassium Citrate
• Other Study ID Numbers: PRENECAL