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

NCT01756547 | Unknown Phase 3 DMC

• 1 other identifier: PRENECAL
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrocalcinosis

Keywords

Nephrocalcinosis; Extreme premature

Outcome Measures

Primary Outcomes (1)

• incidence of nephrocalcinosis in extremely preterm infants

  incidence of nephrocalcinosis in extremely preterm infants

  38-40 weeks of corrected gestational age

Secondary Outcomes (4)

• 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

  38-40 weeks of corrected gestational age

• To determine whether administration of potassium citrate improves the levels of urinary phosphorus, potassium, sodium, citrate, creatinine, oxalate, ratio citrate / calcium , and ph value

  38-40 weeks of corrected gestational age

• Determine whether the administration of potassium citrate improves the plasma levels of sodium, potassium, creatinine, calcium, and ph value.

  38-40 weeks of corrected gestational age

• To determine the incidence of adverse events and serious adverse events related to study treatment.

  38-40 weeks of corrected gestational age

Study Arms (2)

Potassium citrate

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Potassium Citrate DRUG

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.

Potassium citrate

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 7 Days - 16 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Juan A. Arnaiz: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Nephrocalcinosis

Interventions

Potassium Citrate

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Francisco Botet Mussons, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judit Pich Martínez, Pharmacist

CONTACT

0034 93 227 54 00; jpich@clinic.ub.es

Francisco Botet Mussons, MD

CONTACT

fbotet@clinic.ub.es

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Project manager Clinical Trials Unit

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: December 27, 2012
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: December 27, 2012

Record last verified: 2012-12

Locations

ES (1)