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

Primary Purpose

Nephrocalcinosis

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Alkaline citrate

About this trial

This is an interventional prevention trial for Nephrocalcinosis focused on measuring nephrocalcinosis, premature infants, hypocitraturia, alcaline citrate therapy, Nephrocalcinosis in premature infants

Eligibility Criteria

5 Days - 8 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Prof. Dr. Bernd Hoppe

Outcomes

Primary Outcome Measures

Prevention of nephrocalcinosis

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

Secondary Outcome Measures

Increase in urinary citrate excretion

Increase in urinary citrate excretion under prophylactic treatment

Full Information

NCT ID

NCT00249951

First Posted

November 3, 2005

Last Updated

June 29, 2012

Sponsor

University of Cologne

1. Study Identification

Unique Protocol Identification Number

NCT00249951

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

November 2005 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Cologne

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nephrocalcinosis

Keywords

nephrocalcinosis, premature infants, hypocitraturia, alcaline citrate therapy, Nephrocalcinosis in premature infants

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Alkaline citrate

Other Intervention Name(s)

no brand names, Shol's solution versus placebo solution (NaCl 0.9 %)

Intervention Description

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

Primary Outcome Measure Information:

Title

Prevention of nephrocalcinosis

Description

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

Time Frame

First eight weeks of life

Secondary Outcome Measure Information:

Title

Increase in urinary citrate excretion

Description

Increase in urinary citrate excretion under prophylactic treatment

Time Frame

First eight weeks of life

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Days

Maximum Age & Unit of Time

8 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bernd Hoppe, Prof. Dr.

Organizational Affiliation

University Children's Hospital Cologne, Kerpenerstr. 62, D-50924 Cologne, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Prof. Dr. Bernd Hoppe

City

Cologne

ZIP/Postal Code

D-50924

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

12753307

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.

Results Reference

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PubMed Identifier

11956879

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.

Results Reference

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PubMed Identifier

9779963

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.

Results Reference

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PubMed Identifier

8215570

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.

Results Reference

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

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