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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00249951

Enrollment

Registered

2005-11-07

Start date

2005-11-30

Completion date

2008-11-30

Last updated

2012-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrocalcinosis

Keywords

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

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.

Interventions

DRUGAlkaline citrate

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

5 Days to 8 Weeks

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

Design outcomes

Primary

Measure	Time frame	Description
Prevention of nephrocalcinosis	First eight weeks of life	Prevention of the development of nephrocalcinosis under prophylactic treatment with an alkaline citrate prepration.

Secondary

Measure	Time frame	Description
Increase in urinary citrate excretion	First eight weeks of life	Increase in urinary citrate excretion under prophylactic treatment

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026