Status:
COMPLETED
Study Vitamin D in Healthy Individuals
Lead Sponsor:
Fujirebio Diagnostics, Inc.
Conditions:
Vitamin D Deficiency
Eligibility:
All Genders
Brief 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 coll...
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 ...
Eligibility Criteria
Inclusion
- Males and females, age≥ 18 years Able to understand and willing to provide informed consent
Exclusion
- Males and females, age \<18 years Current use of dietary supplements (tablet, liquid gel or liquid form only) containing high concentrations, greater than 2,000 IU per day, of vitamin D.
- Has a history of vitamin D deficiency Has a history or current diagnosis of any clinically significant cardiac, respiratory, neurological, immunological, hematological, liver disease, renal disease, gastrointestinal (GI) disorder, including any history of peptic or gastric ulcers or GI bleeding, or any other condition which, in the opinion of the investigator is considered chronic.
- Personal history of seizures Personal history of bariatric surgery Personal history of parathyroid and thyroid disease Pregnancy or lactation Is receiving systemic chemotherapy or radiation treatment, has an active malignancy of any type, or has been diagnosed with cancer within 5 years before screening other than basal or squamous cell skin cancers or in-situ cervical cancer.
- Family history of parathyroid or calcium regulatory disease Medications known to affect absorption e.g. drugs that inhibit cholesterol absorption Medications known to increase catabolism such as anticonvulsants, glucocorticoids, HAART (AIDS treatment) and anti-rejection medications Unable to provide informed consent
Key Trial Info
Start Date :
May 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
482 Patients enrolled
Trial Details
Trial ID
NCT02250625
Start Date
May 1 2014
End Date
April 1 2015
Last Update
May 22 2015
Active Locations (1)
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1
Open Medicine Institute
Mountain View, California, United States, 94040