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

NCT00249951 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2012-07-03

No results posted yet for this study

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.

Conditions

  • Nephrocalcinosis

Interventions

DRUG

Alkaline citrate

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

Sponsors & Collaborators

  • University of Cologne

    lead OTHER

Principal Investigators

  • Bernd Hoppe, Prof. Dr. · University Children's Hospital Cologne, Kerpenerstr. 62, D-50924 Cologne, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Days
Max Age
8 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00249951 on ClinicalTrials.gov