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

• Sponsor: University of Cologne (Other)
• Overall Status: Completed
• CT.gov ID: NCT00249951
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Duration (Months): 36
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nephrocalcinosis	Drug: Alkaline citrate	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Study Start Date: Nov 1, 2005
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Outcome Measures

Primary Outcome Measures

1. Prevention of nephrocalcinosis [First eight weeks of life]

   Prevention of the development of nephrocalcinosis under prophylactic treatment with an alkaline citrate prepration.

Secondary Outcome Measures

1. Increase in urinary citrate excretion [First eight weeks of life]

   Increase in urinary citrate excretion under prophylactic treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 8 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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, 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.
• 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.
• 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.

• Responsible Party: Prof. Dr. B. Hoppe, Head, Division of Pediatric Nephrology, University of Cologne
• ClinicalTrials.gov Identifier: NCT00249951
• Other Study ID Numbers: FG03-157
• First Posted: Nov 7, 2005
• Last Update Posted: Jul 3, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by Prof. Dr. B. Hoppe, Head, Division of Pediatric Nephrology, University of Cologne: nephrocalcinosis; premature infants; hypocitraturia; alcaline citrate therapy; Nephrocalcinosis in premature infants
• Additional relevant MeSH terms: Nephrocalcinosis

Study Results

No Results Posted as of Jul 3, 2012