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

Nephrocalcinosis Clinical Trial

— PRENECAL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01756547
• Other study ID #: PRENECAL
• Status: Not yet recruiting
• Phase: Phase 3
• First received: December 20, 2012
• Last updated: December 26, 2012
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: December 2012
• Source: Hospital Clinic of Barcelona
• Contact: Judit Pich Martínez, Pharmacist
• Phone: 0034 93 227 54 00
• Email: jpich[@]clinic.ub.es
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nephrocalcinosis

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Juan A. Arnaiz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of nephrocalcinosis in extremely preterm infants	incidence of nephrocalcinosis in extremely preterm infants	38-40 weeks of corrected gestational age	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes