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

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 Intervention Model: Parallel Assignment Masking: Double Blind (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.

Resource links provided by NLM:

MedlinePlus related topics: Potassium

Drug Information available for: Potassium bicarbonate Potassium citrate anhydrous Sodium citrate Citric acid monohydrate Potassium citrate Potassium chloride Potassium cation

Genetic and Rare Diseases Information Center resources: Nephrocalcinosis

U.S. FDA Resources

Further study details as provided by Juan A. Arnaiz, Hospital Clinic of Barcelona:

Primary Outcome Measures:

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:

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
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.
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.
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.


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

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 (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

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


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

Keywords provided by Juan A. Arnaiz, Hospital Clinic of Barcelona:


Nephrocalcinosis Extreme premature

Additional relevant MeSH terms:


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 Diuretics Natriuretic Agents Physiological Effects of Drugs Expectorants Respiratory System Agents Anticoagulants Calcium Chelating Agents Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017

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