NCT01756547

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Juan A. Arnaiz · Academic / Other
• Sex: All
• Age: 7 Days – 16 Weeks
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
DRUG	Placebo

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2012-12-27
• Last updated: 2012-12-27

Locations

1 site across 1 country: Spain