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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. B. Hoppe, University of Cologne
ClinicalTrials.gov Identifier:
NCT00249951
First received: November 3, 2005
Last updated: June 29, 2012
Last verified: June 2012
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Prevention of nephrocalcinosis [ Time Frame: First eight weeks of life ] [ Designated as safety issue: No ]
    Prevention of the development of nephrocalcinosis under prophylactic treatment with an alkaline citrate prepration.


Secondary Outcome Measures:
  • Increase in urinary citrate excretion [ Time Frame: First eight weeks of life ] [ Designated as safety issue: No ]
    Increase in urinary citrate excretion under prophylactic treatment


Enrollment: 80
Study Start Date: November 2005
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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 %)
  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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: November 3, 2005
Last Updated: June 29, 2012
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

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

ClinicalTrials.gov processed this record on July 23, 2014