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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00249951
Other study ID # FG03-157
Secondary ID
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


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
See also
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Not yet recruiting NCT05862207 - Prevalence and Risk Factors of Nephrocalcinosis in Children at Sohag University Hospital
Not yet recruiting NCT01756547 - Study to Assess the Efficacy and Safety of Oral Potassium Citrate on the Prevention of Nephrocalcinosis in Extreme Premature Phase 3
Active, not recruiting NCT04495608 - Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Fluconazole in Hypercalcicuric Patients With Increased 1.25(OH) 2D Levels Phase 2
Completed NCT02438267 - Preterm Infants and Nephrocalcinosis N/A