Study Vitamin D in Healthy Individuals

NCT02250625 | Completed

• 1 other identifier: FDI-88
• Study Type: observational
• Target: 482
• Locations: 1 country
• Sites: 1

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 collection of specimens that will support future assay discovery and validation efforts.

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• Measure Vitamin D in healthy individuals

  1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy men and women greater than or equal to 18 years of age

You may qualify if:

• Males and females, age≥ 18 years Able to understand and willing to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujirebio Diagnostics, Inc.: lead

Study Sites (1)

Open Medicine Institute

Mountain View, California, 94040, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and plasma

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Andreas Kogelnik, MD,PhD

  Open Medicine Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: September 26, 2014
• Study Start: May 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 22, 2015

Record last verified: 2014-05

Locations

US (1)