NCT02250625

Study Vitamin D in Healthy Individuals

A Prospective Collection of Peripheral Blood Specimens to Study Vitamin D in Healthy Individuals

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 482 (actual)
• Sponsor: Fujirebio Diagnostics, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

To obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting specimens from healthy subjects t on vitamin D assays, and to establish a collection of specimens that will support future assay discovery and validation efforts.

Detailed description

1. Obtain matched serum and plasma specimens collected from a minimum of 50 healthy subjects in two geographic areas. Specimens will be used to determine a reference range for a vitamin D assay, used as an aid in the assessment of vitamin D sufficiency in adults. 2. Obtain serum specimens collected from a minimum of an additional 450 healthy subjects in two geographic areas. Specimens will be used to determine a reference range for a vitamin D assay, used as an aid in the assessment of vitamin D sufficiency in adults. 3. To store any remaining specimens for use in future vitamin D assay development and to evaluate as yet undetermined assays for the development of IVDs, including additional vitamin D assays

Conditions

• Vitamin D Deficiency

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-09-26
• Last updated: 2015-05-22

Locations

1 site across 1 country: United States