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

History of Changes

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:

MedlinePlus related topics: Premature Babies

Drug Information available for: Sodium citrate

U.S. FDA Resources

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:

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

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:

Sikora P, Roth B, Kribs A, Michalk DV, Hesse A, Hoppe B. Hypocitraturia is one of the major risk factors for nephrocalcinosis in very low birth weight (VLBW) infants. Kidney Int. 2003 Jun;63(6):2194-9.

Hoppe B, Duran I, Martin A, Kribs A, Benz-Bohm G, Michalk DV, Roth B. Nephrocalcinosis in preterm infants: a single center experience. Pediatr Nephrol. 2002 Apr;17(4):264-8.

Hoppe B, Roth B, Bauerfeld C, Langman CB. Oxalate, citrate, and sulfate concentration in human milk compared with formula preparations: influence on urinary anion excretion. J Pediatr Gastroenterol Nutr. 1998 Oct;27(4):383-6.

Hoppe B, Hesse A, Neuhaus T, Fanconi S, Forster I, Blau N, Leumann E. Urinary saturation and nephrocalcinosis in preterm infants: effect of parenteral nutrition. Arch Dis Child. 1993 Sep;69(3 Spec No):299-303.

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 May 19, 2013

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