NCT00249951

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

July 3, 2012

Status Verified

June 1, 2012

Enrollment Period

3 years

First QC Date

November 3, 2005

Last Update Submit

June 29, 2012

Conditions

Nephrocalcinosis

Keywords

nephrocalcinosispremature infantshypocitraturiaalcaline citrate therapyNephrocalcinosis in premature infants

Outcome Measures

Primary Outcomes (1)

  • Prevention of nephrocalcinosis

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

    First eight weeks of life

Secondary Outcomes (1)

  • Increase in urinary citrate excretion

    First eight weeks of life

Interventions

Alkaline citrateDRUG

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

Also known as: no brand names, Shol's solution versus placebo solution (NaCl 0.9 %)

Eligibility Criteria

Age5 Days - 8 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm infants \< 32 weeks gestation age and \< 1500 g birth weight

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Bernd Hoppe

Cologne, D-50924, Germany

Location

Related Publications (4)

  • 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.

    PMID: 12753307BACKGROUND

  • 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.

    PMID: 11956879BACKGROUND

  • 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.

    PMID: 9779963BACKGROUND

  • 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.

    PMID: 8215570BACKGROUND

MeSH Terms

Conditions

NephrocalcinosisPremature Birth

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCalcinosisCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy Complications

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Bernd Hoppe, Prof. Dr.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Division of Pediatric Nephrology

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 7, 2005

Study Start

November 1, 2005

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

July 3, 2012

Record last verified: 2012-06

Locations

DE(1)