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

This study is currently recruiting participants.
Verified by University of Cologne, November 2005

Sponsored by: University of Cologne
Information provided by: University of Cologne
ClinicalTrials.gov Identifier: NCT00249951
  Purpose

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.


Condition Intervention Phase
Nephrocalcinosis
Drug: Alkaline citrate
Phase III

ChemIDplus related topics:   Citric acid    Sodium Citrate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Prevention of nephrocalcinosis

Secondary Outcome Measures:
  • Increase in urinary citrate excretion

Estimated Enrollment:   80
Study Start Date:   November 2005

  Eligibility
Ages Eligible for Study:   up to 8 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249951

Contacts
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    

Locations
Germany
Prof. Dr. Bernd Hoppe     Recruiting
      Cologne, Germany, D-50924
      Contact: Bernd Hoppe, Prof. Dr.     01149 221 478 4391     bernd.hoppe@uk-koeln.de    
      Principal Investigator: Bernd Hoppe, Prof. Dr.            

Sponsors and Collaborators
University of Cologne

Investigators
Principal Investigator:     Bernd Hoppe, Prof. Dr.     University Children's Hospital Cologne, Kerpenerstr. 62, D-50924 Cologne, Germany    
  More Information


Publications:

Study ID Numbers:   FG03-157
First Received:   November 3, 2005
Last Updated:   November 14, 2005
ClinicalTrials.gov Identifier:   NCT00249951
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:
nephrocalcinosis  
premature infants  
hypocitraturia  
alcaline citrate therapy  
Nephrocalcinosis in premature infants  

Study placed in the following topic categories:
Calcinosis
Metabolic Diseases
Urologic Diseases
Citric Acid
Kidney Diseases
Metabolic disorder
Nephrocalcinosis

Additional relevant MeSH terms:
Calcium Metabolism Disorders

ClinicalTrials.gov processed this record on October 10, 2008




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