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Clinical trialNCT01105689CompletedObservational

Utility of a Urine Screening Tool for Vitamin D Deficiency in Infants and Toddlers

SponsorNemours Children's ClinicEnrollment60Vitamin D Deficiency
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Background: Vitamin D plays a key role in calcium absorption in the gut and in skeletal development. Vitamin D deficiency is common, affecting an estimated one billion people worldwide, including developed countries. Vitamin D deficiency causes rickets, the most common non-communicable disease of childhood. Rickets causes poor growth and skeletal deformities and, at its most severe, seizures and death. Recent data suggest that children with rickets have an increased risk for developing diabetes mellitus. Screening for vitamin D deficiency is not commonly done. It is generally diagnosed only after symptoms of rickets have developed. Prevention and treatment is simple and inexpensive. Hence, early detection of vitamin D deficiency through screening would be beneficial. Studies are urgently needed to validate such screening tests. Calcium balance is tightly regulated in the body and calcium loss in the urine (measured by the urine calcium-to-creatinine ratio) is a sensitive indicator of reduced calcium absorption, such as in vitamin D deficiency. Objective and Hypotheses. The objective of this study is to evaluate the urine calcium-to-creatinine ratio as a noninvasive and inexpensive screening test for vitamin D deficiency. Our hypotheses are 1) that the urine calcium-to-creatinine ratio correlates with blood vitamin D levels in infants and toddlers at risk for vitamin D deficiency and 2) that this test can be used to screen for vitamin D deficiency. Potential Impact. A validated screening tool would allow for the detection of vitamin D deficiency before the development of rickets, decreasing the morbidity and mortality of this common disease.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Nemours Children'S Clinic

    Jacksonville, Florida, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Mar 2010
Primary completion
31 Jul 2011
Completion
31 Jul 2011
Last update posted
9 Sept 2011
Registered enrollment
60
Registry id
NCT01105689

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.