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

NCT ID: NCT00249951

Last Updated: 2012-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Nephrocalcinosis

Keywords

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nephrocalcinosis premature infants hypocitraturia alcaline citrate therapy Nephrocalcinosis in premature infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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Alkaline citrate

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

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

5 Days

Maximum Eligible Age

8 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. B. Hoppe

Head, Division of Pediatric Nephrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernd Hoppe, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Prof. Dr. Bernd Hoppe

Cologne, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 12753307 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11956879 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9779963 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8215570 (View on PubMed)

Other Identifiers

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FG03-157

Identifier Type: -

Identifier Source: org_study_id