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

Arm | Intervention/treatment |
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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.
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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.
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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.
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Drug: Placebo |
- incidence of nephrocalcinosis in extremely preterm infants [ Time Frame: 38-40 weeks of corrected gestational age ]incidence of nephrocalcinosis in extremely preterm infants
- 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.

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Ages Eligible for Study: | up to 16 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
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 |
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 |
Principal Investigator: | Francisco Botet Mussons, MD | Hospital Clinic of Barcelona |
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:
Premature Birth Nephrocalcinosis Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Kidney Diseases Urologic Diseases Calcinosis Calcium Metabolism Disorders Metabolic Diseases Citric Acid |
Potassium 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 |