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

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ClinicalTrials.gov Identifier: NCT01756547
Recruitment Status : Unknown
Verified December 2012 by Juan A. Arnaiz, Hospital Clinic of Barcelona.
Recruitment status was:  Not yet recruiting
First Posted : December 27, 2012
Last Update Posted : December 27, 2012
Sponsor:
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona

Study Description
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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.

Condition or disease Intervention/treatment Phase
Nephrocalcinosis Drug: Potassium Citrate Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : January 2013
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. incidence of nephrocalcinosis in extremely preterm infants [ Time Frame: 38-40 weeks of corrected gestational age ]
    incidence of nephrocalcinosis in extremely preterm infants


Secondary Outcome Measures :
  1. 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 ]
    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

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. To determine the incidence of adverse events and serious adverse events related to study treatment. [ Time Frame: 38-40 weeks of corrected gestational age ]
    To determine the incidence of adverse events and serious adverse events related to study treatment.


Eligibility Criteria
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Ages Eligible for Study:   up to 16 Weeks   (Child)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01756547


Contacts
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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
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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
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Principal Investigator: Francisco Botet Mussons, MD Hospital Clinic of Barcelona
More Information
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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
First Posted: December 27, 2012    Key Record Dates
Last Update Posted: December 27, 2012
Last Verified: December 2012
Keywords provided by Juan A. Arnaiz, Hospital Clinic of Barcelona:
Nephrocalcinosis
Extreme premature
Additional relevant MeSH terms:
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Premature Birth
Nephrocalcinosis
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Kidney Diseases
Urologic Diseases
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases
Potassium Citrate
Citric Acid
 Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Expectorants
Respiratory System Agents