Alkaline Citrate Treatment to Lower the Risk of Nephrocalcinosis in Preterm Infants
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ClinicalTrials.gov Identifier: NCT00249951 |
Recruitment Status :
Completed
First Posted : November 7, 2005
Last Update Posted : July 3, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nephrocalcinosis | Drug: Alkaline citrate | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
Study Start Date : | November 2005 |
Actual Primary Completion Date : | November 2008 |
Actual Study Completion Date : | November 2008 |

- Drug: Alkaline citrate
Prophylactic alkaline citrate medication during the first 8 weeks of life versus placebo solution to prevent nephrocalcinosis of prematurity.Other Name: no brand names, Shol's solution versus placebo solution (NaCl 0.9 %)
- Prevention of nephrocalcinosis [ Time Frame: First eight weeks of life ]Prevention of the development of nephrocalcinosis under prophylactic treatment with an alkaline citrate prepration.
- Increase in urinary citrate excretion [ Time Frame: First eight weeks of life ]Increase in urinary citrate excretion under prophylactic treatment

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Ages Eligible for Study: | up to 8 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00249951
Germany | |
Prof. Dr. Bernd Hoppe | |
Cologne, Germany, D-50924 |
Principal Investigator: | Bernd Hoppe, Prof. Dr. | University Children's Hospital Cologne, Kerpenerstr. 62, D-50924 Cologne, Germany |
Responsible Party: | Prof. Dr. B. Hoppe, Head, Division of Pediatric Nephrology, University of Cologne |
ClinicalTrials.gov Identifier: | NCT00249951 |
Other Study ID Numbers: |
FG03-157 |
First Posted: | November 7, 2005 Key Record Dates |
Last Update Posted: | July 3, 2012 |
Last Verified: | June 2012 |
nephrocalcinosis premature infants hypocitraturia alcaline citrate therapy Nephrocalcinosis in premature infants |
Nephrocalcinosis Kidney Diseases Urologic Diseases |
Calcinosis Calcium Metabolism Disorders Metabolic Diseases |