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

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.

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Key information

Conditions

Nephrocalcinosis Calcinosis Calcium Metabolism Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases Urologic Diseases

Age range

5 day–8 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Prof. Dr. Bernd Hoppe

Cologne, D-50924, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alkaline citrate

Drug

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

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

Primary outcomes

Prevention of nephrocalcinosis

Time frame: First eight weeks of life

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

Secondary outcomes

Increase in urinary citrate excretion

Time frame: First eight weeks of life

Increase in urinary citrate excretion under prophylactic treatment

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Important dates

Study start: 2005
Primary completion: 2008
Study completion: 2008
First posted: Nov 7, 2005
Registry last updated: Jul 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed