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Alkaline Citrate Treatment to Lower the Risk of Nephrocalcinosis in Preterm Infants
This study is currently recruiting participants.
Study NCT00249951   Information provided by University of Cologne
First Received: November 3, 2005   Last Updated: November 14, 2005   History of Changes

November 3, 2005
November 14, 2005
November 2005
 
Prevention of nephrocalcinosis
Same as current
Complete list of historical versions of study NCT00249951 on ClinicalTrials.gov Archive Site
Increase in urinary citrate excretion
Same as current
 
Alkaline Citrate Treatment to Lower the Risk of Nephrocalcinosis in Preterm Infants
 

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.

 
Phase III
Interventional
Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double-Blind
Primary Purpose:  Prevention
Nephrocalcinosis
Drug: Alkaline citrate
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
80
 
 

Inclusion Criteria:

  • Preterm infants < 32 weeks gestation age and < 1500 g birth weight

Exclusion Criteria:

  • Cardial, renal or gastrointestinal malformations
  • Chronic renal failure
  • Therapy with vitamin B6
  • High dose treatment with furosemide or dexamethasone
  • Addison's disease
  • Severe metabolic alkalosis
  • Worse clinical condition of preterm infant, which makes oral feeding impossible
  • Participation in other studies
Both
up to 8 Weeks
No
Contact: Bernd Hoppe, Prof. Dr. 01149 221 478 4391 bernd.hoppe@uk-koeln.de
Contact: Bodo B Beck, MD 01149 221 478 4391 bodobbeck@aol.com
Germany
 
NCT00249951
 
FG03-157
University of Cologne
 
Principal Investigator: Bernd Hoppe, Prof. Dr. University Children's Hospital Cologne, Kerpenerstr. 62, D-50924 Cologne, Germany
University of Cologne
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP