Clinical trial NCT00249951: Alkaline Citrate Treatment to Lower the Risk of Nephrocalcinosis in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nephrocalcinosis
Keywords: nephrocalcinosis
premature infants
hypocitraturia
alcaline citrate therapy
Nephrocalcinosis in premature infants
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2005-11-07
Enrollment: 80
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Prevention of nephrocalcinosis
timeFrame: First eight weeks of life
Secondary outcomes:
measure: Increase in urinary citrate excretion
timeFrame: First eight weeks of life
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Prof. Dr. Bernd Hoppe
Study officials:
affiliation: University Children's Hospital Cologne, Kerpenerstr. 62, D-50924 Cologne, Germany
name: Bernd Hoppe, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1046/j.1523-1755.2003.t01-4-00001.x.
citation: 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. doi: 10.1007/s00467-001-0816-8.
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. doi: 10.1097/00005176-199810000-00002.
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. doi: 10.1136/adc.69.3_spec_no.299.