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

Primary Purpose

Nephrocalcinosis

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Potassium Citrate
Placebo
Sponsored by
Juan A. Arnaiz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nephrocalcinosis focused on measuring Nephrocalcinosis, Extreme premature

Eligibility Criteria

7 Days - 16 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Clínic de Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Potassium citrate

Placebo

Arm Description

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.

Oral solution 30ml, that contains distilled water and simple syrup, in the same dose like the active treatment 0,3ml/kg/day.

Outcomes

Primary Outcome Measures

incidence of nephrocalcinosis in extremely preterm infants
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
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
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.
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.
To determine the incidence of adverse events and serious adverse events related to study treatment.

Full Information

First Posted
December 20, 2012
Last Updated
December 26, 2012
Sponsor
Juan A. Arnaiz
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1. Study Identification

Unique Protocol Identification Number
NCT01756547
Brief Title
Study to Assess the Efficacy and Safety of Oral Potassium Citrate on the Prevention of Nephrocalcinosis in Extreme Premature
Acronym
PRENECAL
Official Title
Study to Assess the Efficacy and Safety of Oral Potassium Citrate on the Prevention of Nephrocalcinosis in Extreme Premature.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
January 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juan A. Arnaiz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrocalcinosis
Keywords
Nephrocalcinosis, Extreme premature

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Potassium citrate
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral solution 30ml, that contains distilled water and simple syrup, in the same dose like the active treatment 0,3ml/kg/day.
Intervention Type
Drug
Intervention Name(s)
Potassium Citrate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
incidence of nephrocalcinosis in extremely preterm infants
Description
incidence of nephrocalcinosis in extremely preterm infants
Time Frame
38-40 weeks of corrected gestational age
Secondary Outcome Measure Information:
Title
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
Description
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
Title
To determine whether administration of potassium citrate improves the levels of urinary phosphorus, potassium, sodium, citrate, creatinine, oxalate, ratio citrate / calcium , and ph value
Description
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.
Time Frame
38-40 weeks of corrected gestational age
Title
Determine whether the administration of potassium citrate improves the plasma levels of sodium, potassium, creatinine, calcium, and ph value.
Description
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.
Time Frame
38-40 weeks of corrected gestational age
Title
To determine the incidence of adverse events and serious adverse events related to study treatment.
Description
To determine the incidence of adverse events and serious adverse events related to study treatment.
Time Frame
38-40 weeks of corrected gestational age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
16 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Premature infants of both sexes born at the Hospital Clinic of Barcelona. Corrected gestational age below 32 weeks and lower birth weight 1500gr. Survivors at 7 days old. Clinically stable, in the opinion of the investigator, at the time of inclusion. 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: Renal malformations, cardiac or gastrointestinal prenatal or postnatal diagnosis. 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) Treatment with furosemide or dexamethasone Addison's disease. Persistent severe metabolic alkalosis. Impossibility of oral feeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judit Pich Martínez, Pharmacist
Phone
0034 93 227 54 00
Ext
2815
Email
jpich@clinic.ub.es
First Name & Middle Initial & Last Name or Official Title & Degree
Francisco Botet Mussons, MD
Email
fbotet@clinic.ub.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Botet Mussons, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judit Pich Martínez, Pharmacist
Phone
0034 93 227 54 00
Ext
2815
Email
jpich@clinic.ub.es
First Name & Middle Initial & Last Name & Degree
Francisco Botet Mussons, MD
Email
fbotet@clinic.ub.es
First Name & Middle Initial & Last Name & Degree
Francisco Botet Mussons, MD

12. IPD Sharing Statement

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

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