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NCT01105689 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Nemours Children's Clinic.

Completed
Registry status
60
Enrollment target

NCT01105689 is a clinical trial that has completed, run by Nemours Children's Clinic. The registered enrollment target is 60 participants.

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The verdict

NCT01105689 has completed, sponsored by Nemours Children's Clinic.

COMPLETED
Registry status
60 participants
Enrollment target

Study Summary

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.

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2010-03
Est. Completion 2011-07

Sponsor

Nemours Children's Clinic

108 total trials

What the Registry Record Tells You About NCT01105689

The ClinicalTrials.gov registry entry for NCT01105689 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT01105689 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01105689 about?

NCT01105689 is a clinical study titled "Utility of a Urine Screening Tool for Vitamin D Deficiency in Infants and Toddlers". 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 c...

What is the current status of trial NCT01105689?

This trial is currently completed. The enrollment target is 60 participants. The study started on 2010-03. Estimated completion is 2011-07.

Who is sponsoring clinical trial NCT01105689?

This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.