Clinical Trials Logo

Clinical Trial Summary

Preterm infants are at risk to develop nephrocalcinosis. Incidence numbers vary according to birth weight and gestation age. Very low birth weight infants have the highest risk index, with ~ 7-10 % of preterm infants developing nephrocalcinosis in the patient population. We, the researchers at the University of Cologne, and others found significantly decreased urinary citrate excretion (hypocitraturia) to be one of the main risk factors. Hence, we hypothesized, that prophylactic treatment with oral alkaline citrate solution (Shol's solution) would help to 1) increase urinary citrate excretion and 2) help to decrease the incidence of nephrocalcinosis.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00249951
Study type Interventional
Source University of Cologne
Contact
Status Completed
Phase Phase 3
Start date November 2005
Completion date November 2008

See also
  Status Clinical Trial Phase
Withdrawn NCT00875823 - International Registry for Primary Hyperoxaluria N/A
Completed NCT04382976 - The Incidence and the Risk Factors of Nephrocalcinosis in Very Preterm Infants
Recruiting NCT00169806 - Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis N/A
Not yet recruiting NCT05862207 - Prevalence and Risk Factors of Nephrocalcinosis in Children at Sohag University Hospital
Not yet recruiting NCT01756547 - Study to Assess the Efficacy and Safety of Oral Potassium Citrate on the Prevention of Nephrocalcinosis in Extreme Premature Phase 3
Active, not recruiting NCT04495608 - Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Fluconazole in Hypercalcicuric Patients With Increased 1.25(OH) 2D Levels Phase 2
Completed NCT02438267 - Preterm Infants and Nephrocalcinosis N/A