Vitamin D Serum LevelsNCT05641818
Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 3 (VITAD/3)
An observational study of Vitamin D Serum Levels, run by Institute of Nutrition, Slovenia (Nutris) at 1 site in Slovenia.
Trial summary
Validation of a screening tool for identification of subjects at risk for suboptimal vitamin D status. Developed questionnaire-based screening tool will be used on subjects with various risks for vitamin D deficiency, and compared with 25-OH-vitamin D levels. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Serum Levels
- What is being tested?
- Screening tool for vitamin D deficiency
- How many people
- 400 participants
- Where
- 1 siteSlovenia
- Study dates
- 5 Dec 2022to 1 Dec 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult users and non-users of vitamin D drugs and food supplements living in Slovenia. Participants invited from the database at Nutrition Institute.
Who may be able to join
- Signed Informed consent form (ICF),
- Age between 18 and 65 years at the time of the signature of Informed consent form (ICF),
- Did not change use of vitamin D conatining drugs/supplements for last 6 weeks
- Willingness to follow all study procedures
Who cannot join
- Pregnancy or breastfeeding,
- Change in use of food supplements containing Vitamin D in last 6 weeks
- Acute ilness
- Mental incapacity that precludes adequate understanding or cooperation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 3: Screening Tool for Identification of Subjects at Risk for Suboptimal Vitamin D Status
Validation of a screening tool for identification of subjects at risk for suboptimal vitamin D status. Developed questionnaire-based screening tool will be used on subjects with various risks for vitamin D deficiency, and compared with 25-OH-vitamin D levels.
- Conditions
- Vitamin D Serum Levels
- Being tested
- Screening tool for vitamin D deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening tool for vitamin D deficiencyOther
(1) Determination of 25(OH) Vitamin D3 in human serum samples and (2) Question based screening tool with personal (age, gender,...), lifestyle (e.g. sun exposure, outdoor activity) and dietary factors that affect the status of vitamin D in the human body.
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between vitamin D status (deficiency) assessed by two different methods
Vitamin D serum level will be measured for assessment of Vitamin D status. Risk for vitamin D deficiency will be assessed using questionaire-based screening tool. Two methods will be compared.
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 posted8 Dec 2022
- Study start5 Dec 2022
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D Serum LevelsStudies 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
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Nutrition, Slovenia (Nutris)
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Public Health, Slovenia, VIST - Faculty of Applied Sciences, Slovenian Research Agency
- Responsible party
- Sponsor
- Investigators
- Igor Pravst, PhD, Study chair, Institut za nutricionistikoKatja Žmitek, PhD, Principal investigator, VIST - Faculty of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641818
- Sponsor's protocol ID
- VITAD-01-2018 Part 3
- Status last verified
- Dec 2022
- First submitted
- 29 Nov 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Challenges in Achieving Adequate Vitamin D Status in the Adult Population - Part 3: Screening Tool for Identification of Subjects at Risk for Suboptimal Vitamin D Status
- ClinicalTrials.gov ID
- NCT05641818
- Acronym / sponsor ID
- VITAD-01-2018 Part 3
- Conditions
- Vitamin D Serum Levels
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Institute of Nutrition, Slovenia (Nutris)University, hospital or other
- Collaborators
- National Institute of Public Health, Slovenia, VIST - Faculty of Applied Sciences, Slovenian Research Agency
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 8 Dec 2022 (actual)
- 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.
Validation of a screening tool for identification of subjects at risk for suboptimal vitamin D status. Developed questionnaire-based screening tool will be used on subjects with various risks for vitamin D deficiency, and compared with 25-OH-vitamin D levels.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult users and non-users of vitamin D drugs and food supplements living in Slovenia. Participants invited from the database at Nutrition Institute.
Key inclusion criteria (4 listed)
- Signed Informed consent form (ICF),
- Age between 18 and 65 years at the time of the signature of Informed consent form (ICF),
- Did not change use of vitamin D conatining drugs/supplements for last 6 weeks
- Willingness to follow all study procedures
Key exclusion criteria (4 listed)
- Pregnancy or breastfeeding,
- Change in use of food supplements containing Vitamin D in last 6 weeks
- Acute ilness
- Mental incapacity that precludes adequate understanding or cooperation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening tool for vitamin D deficiency(1) Determination of 25(OH) Vitamin D3 in human serum samples and (2) Question based screening tool with personal (age, gender,...), lifestyle (e.g. sun exposure, outdoor activity) and dietary factors that affect the status of vitamin D in the human body. | Other | – |
Primary outcome
Difference between vitamin D status (deficiency) assessed by two different methods
Time frame: 1 year
Vitamin D serum level will be measured for assessment of Vitamin D status. Risk for vitamin D deficiency will be assessed using questionaire-based screening tool. Two methods will be compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Individual participant dataSharing planned: Undecided. Not decided yet
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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.
Igor Pravst, PhD study chair
Institut za nutricionistiko
Katja Žmitek, PhD principal investigator
VIST - Faculty of Applied Sciences
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 Serum Levels, run by Institute of Nutrition, Slovenia (Nutris) at 1 site in Slovenia.
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 4 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: status not confirmed, as of the sponsor's last update on 14 Dec 2022. 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 Slovenia. 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?
Results are not available in the source record.
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?
Difference between vitamin D status (deficiency) assessed by two different methods (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 14 Dec 2022.