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

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ClinicalTrials.gov Identifier: NCT00249951
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : July 3, 2012
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. B. Hoppe, University of Cologne

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.

Condition or disease Intervention/treatment Phase
Nephrocalcinosis Drug: Alkaline citrate Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Study Start Date : November 2005
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Alkaline citrate
    Prophylactic alkaline citrate medication during the first 8 weeks of life versus placebo solution to prevent nephrocalcinosis of prematurity.
    Other Name: no brand names, Shol's solution versus placebo solution (NaCl 0.9 %)


Primary Outcome Measures :
  1. Prevention of nephrocalcinosis [ Time Frame: First eight weeks of life ]
    Prevention of the development of nephrocalcinosis under prophylactic treatment with an alkaline citrate prepration.


Secondary Outcome Measures :
  1. Increase in urinary citrate excretion [ Time Frame: First eight weeks of life ]
    Increase in urinary citrate excretion under prophylactic treatment



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Ages Eligible for Study:   up to 8 Weeks   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00249951


Locations
Germany
Prof. Dr. Bernd Hoppe
Cologne, Germany, D-50924
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Bernd Hoppe, Prof. Dr. University Children's Hospital Cologne, Kerpenerstr. 62, D-50924 Cologne, Germany

Publications:
Responsible Party: Prof. Dr. B. Hoppe, Head, Division of Pediatric Nephrology, University of Cologne
ClinicalTrials.gov Identifier: NCT00249951     History of Changes
Other Study ID Numbers: FG03-157
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: July 3, 2012
Last Verified: June 2012

Keywords provided by Prof. Dr. B. Hoppe, University of Cologne:
nephrocalcinosis
premature infants
hypocitraturia
alcaline citrate therapy
Nephrocalcinosis in premature infants

Additional relevant MeSH terms:
Nephrocalcinosis
Kidney Diseases
Urologic Diseases
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases
Citric Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action