Nephrocalcinosis | Study to Assess the Efficacy and Safety of Oral Potassium Citrate on the Prevention of Nephrocalcinosis in Extreme Premature
Nephrocalcinosis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Potassium CitratePotassium 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Potassium citratePotassium 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.
PlaceboOral solution 30ml, that contains distilled water and simple syrup, in the same dose like the active treatment 0,3ml/kg/day.
Start Date: January 2013
Completed Date: January 2014
Phase: Phase 3
Primary Outcome: incidence of nephrocalcinosis in extremely preterm infants
Secondary Outcome: 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
Study sponsors, principal investigator, and references
Principal Investigator: Francisco Botet Mussons, MD
Lead Sponsor: Juan A. Arnaiz