drugset / Trial / NCT00249951

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

NCT00249951 ↗

Phase 3 Completed 80 enrolled University of Cologne
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2005-11
Primary completion
2008-11
Completion
2008-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Alkaline citrate Unknown — Oral

Indications