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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief 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.

Detailed Summary:
Sponsor: University of Cologne

Current Primary Outcome: Prevention of nephrocalcinosis [ Time Frame: First eight weeks of life ]

Prevention of the development of nephrocalcinosis under prophylactic treatment with an alkaline citrate prepration.


Original Primary Outcome: Prevention of nephrocalcinosis

Current Secondary Outcome: Increase in urinary citrate excretion [ Time Frame: First eight weeks of life ]

Increase in urinary citrate excretion under prophylactic treatment


Original Secondary Outcome: Increase in urinary citrate excretion

Information By: University of Cologne

Dates:
Date Received: November 3, 2005
Date Started: November 2005
Date Completion:
Last Updated: June 29, 2012
Last Verified: June 2012