Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    "Nephrocalcinosis" | "Chelating Agents"
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 3, 2005
First Posted Date  ICMJE November 7, 2005
Last Update Posted Date July 3, 2012
Study Start Date  ICMJE November 2005
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2012)
Prevention of nephrocalcinosis [ Time Frame: First eight weeks of life ]
Prevention of the development of nephrocalcinosis under prophylactic treatment with an alkaline citrate prepration.
Original Primary Outcome Measures  ICMJE
 (submitted: November 3, 2005)
Prevention of nephrocalcinosis
Change History Complete list of historical versions of study NCT00249951 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2012)
Increase in urinary citrate excretion [ Time Frame: First eight weeks of life ]
Increase in urinary citrate excretion under prophylactic treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2005)
Increase in urinary citrate excretion
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alkaline Citrate Treatment to Lower the Risk of Nephrocalcinosis in Preterm Infants
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Nephrocalcinosis
Intervention  ICMJE 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 %)
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2005)
80
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 8 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00249951
Other Study ID Numbers  ICMJE FG03-157
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Dr. B. Hoppe, University of Cologne
Study Sponsor  ICMJE University of Cologne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bernd Hoppe, Prof. Dr. University Children's Hospital Cologne, Kerpenerstr. 62, D-50924 Cologne, Germany
PRS Account University of Cologne
Verification Date June 2012

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