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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by Hospital Clinic of Barcelona
Sponsor:
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01756547
First received: December 20, 2012
Last updated: December 26, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Nephrocalcinosis
Drug: Potassium Citrate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Study to Assess the Efficacy and Safety of Oral Potassium Citrate on the Prevention of Nephrocalcinosis in Extreme Premature.

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • incidence of nephrocalcinosis in extremely preterm infants [ Time Frame: 38-40 weeks of corrected gestational age ] [ Designated as safety issue: Yes ]
    incidence of nephrocalcinosis in extremely preterm infants


Secondary Outcome Measures:
  • 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 [ Time Frame: 38-40 weeks of corrected gestational age ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 38-40 weeks of corrected gestational age ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 38-40 weeks of corrected gestational age ] [ Designated as safety issue: Yes ]
    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.

  • To determine the incidence of adverse events and serious adverse events related to study treatment. [ Time Frame: 38-40 weeks of corrected gestational age ] [ Designated as safety issue: Yes ]
    To determine the incidence of adverse events and serious adverse events related to study treatment.


Estimated Enrollment: 74
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 16 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756547

Contacts
Contact: Judit Pich Martínez, Pharmacist 0034 93 227 54 00 ext 2815 jpich@clinic.ub.es
Contact: Francisco Botet Mussons, MD fbotet@clinic.ub.es

Locations
Spain
Hospital Clínic de Barcelona Not yet recruiting
Barcelona, Spain, 08036
Contact: Judit Pich Martínez, Pharmacist    0034 93 227 54 00 ext 2815    jpich@clinic.ub.es   
Contact: Francisco Botet Mussons, MD       fbotet@clinic.ub.es   
Principal Investigator: Francisco Botet Mussons, MD         
Sponsors and Collaborators
Juan A. Arnaiz
Investigators
Principal Investigator: Francisco Botet Mussons, MD Hospital Clinic of Barcelona
  More Information

No publications provided

Responsible Party: Juan A. Arnaiz, Project manager Clinical Trials Unit, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01756547     History of Changes
Other Study ID Numbers: PRENECAL
Study First Received: December 20, 2012
Last Updated: December 26, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:
Nephrocalcinosis
Extreme premature

Additional relevant MeSH terms:
Nephrocalcinosis
Kidney Diseases
Urologic Diseases
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases
Citric Acid
Potassium Citrate
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Expectorants
Respiratory System Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 24, 2014