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

Nephrocalcinosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00249951
• Other study ID #: FG03-157
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2005
• Last updated: June 29, 2012
• Start date: November 2005
• Est. completion date: November 2008

Study information

• Verified date: June 2012
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 8 Weeks

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Nephrocalcinosis

Intervention

Drug:
• Alkaline citrate
Prophylactic alkaline citrate medication during the first 8 weeks of life versus placebo solution to prevent nephrocalcinosis of prematurity.

Locations

Country	Name	City	State
Germany	Prof. Dr. Bernd Hoppe	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of nephrocalcinosis	Prevention of the development of nephrocalcinosis under prophylactic treatment with an alkaline citrate prepration.	First eight weeks of life	No
Secondary	Increase in urinary citrate excretion	Increase in urinary citrate excretion under prophylactic treatment	First eight weeks of life	No