CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 80 enrolled
Drug / intervention
Alkaline citratedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00249951
NCT00249951Phase 3Completed
CompareCT.gov

Alkaline Citrate Treatment to Lower the Risk of Nephrocalcinosis in Preterm Infants

University of Cologne·interventional·Posted Nov 7, 2005·Updated Jul 3, 2012

In Brief

A Phase 3 clinical trial evaluating Alkaline citrate for Nephrocalcinosis. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNephrocalcinosis
CountriesGermany
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 7, 2005
Enrollment StartNov 1, 2005
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.7 years ago

Interventions

Alkaline citratedrug

Prophylactic alkaline citrate medication during the first 8 weeks of life versus placebo solution to prevent nephrocalcinosis of prematurity.