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

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

Tracking Information

• First Submitted Date: November 3, 2005
• First Posted Date: November 7, 2005
• Last Update Posted Date: July 3, 2012
• Study Start Date: November 2005
• Actual Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 (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 (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: Alkaline Citrate Treatment to Lower the Risk of Nephrocalcinosis in Preterm Infants
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Prevention
• Condition: Nephrocalcinosis

Intervention

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: Not Provided

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 3, 2005): 80
• Original Enrollment: Same as current
• Actual Study Completion Date: November 2008
• Actual Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 8 Weeks (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00249951
• Other Study ID Numbers: FG03-157
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Prof. Dr. B. Hoppe, University of Cologne
• Study Sponsor: University of Cologne
• Collaborators: Not Provided

Investigators

• 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