Vitamin D DeficiencyNCT02250625
Study Vitamin D in Healthy Individuals
An observational study of Vitamin D Deficiency, run by Fujirebio Diagnostics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- How many people
- 482 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy men and women greater than or equal to 18 years of age
Who may be able to join
- Males and females, age≥ 18 years Able to understand and willing to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Open Medicine Institute
Mountain View, California, 94040
About this study
Official title: A Prospective Collection of Peripheral Blood Specimens to Study Vitamin D in Healthy Individuals
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.
Read the detailed description
- 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.
- 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.
- 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
- Medical subject headings
- Vitamin D Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Vitamin D in healthy individuals
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujirebio Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas Kogelnik, MD,PhD, Principal investigator, Open Medicine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250625
- Sponsor's protocol ID
- FDI-88
- Status last verified
- May 2014
- First submitted
- 24 Sep 2014
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Collection of Peripheral Blood Specimens to Study Vitamin D in Healthy Individuals
- ClinicalTrials.gov ID
- NCT02250625
- Acronym / sponsor ID
- FDI-88
- Conditions
- Vitamin D Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 482 participants (actual)
- Lead sponsor
- Fujirebio Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy men and women greater than or equal to 18 years of age
Key inclusion criteria (1 listed)
- Males and females, age≥ 18 years Able to understand and willing to provide informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure Vitamin D in healthy individuals
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Kogelnik, MD,PhD principal investigator
Open Medicine Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency, run by Fujirebio Diagnostics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure Vitamin D in healthy individuals (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2015; AzTrials last refreshed its copy on 30 Oct 2026.