Vitamin D DeficiencyEvidenceQNCT04404842
Development of a Screening Tool for the Risk of Vitamin D Deficiency
An observational study of Vitamin D Deficiency and Vitamin D3 Deficiency, run by University of Pavia at 1 site in Italy.
Trial summary
Since vitamin D deficiency is a condition that affects a high percentage of individuals of all ages and given the attention on the possible role of the deficiency of this vitamin in the development of various chronic diseases, including cardiovascular and metabolic disease (obesity, insulin resistance, hypertension… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D Deficiency, Vitamin D3 Deficiency, Vitamin D
- How many people
- 190 participants
- Where
- 1 siteItaly
- Study dates
- 14 Jan 2020to 31 Jan 2022
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Psychometric literature suggests that about 5-10 subjects should be recruited for each item (Steiner DL et al, 2015). Considering the number of items in the questionnaire, equal to 19, the number of subjects to enlist will be about 190. Consecutively recruited adult patients by the Service of Dietetics and Clinical Nutrition, Unit of Internal Medicine and Endocrinology, of both sexes.
Who may be able to join
- Subjects older than or equal 18 years;
- Absence of liver pathologies;
- Absence of kidney pathologies;
- Absence of intestinal malabsorption syndromes;
- Absence of bariatric surgery;
- Absence of cancer;
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- Absence of primary hyperparathyroidism;
- Absence of extensive dermatological pathologies (e.g. psoriasis, atopic dermatitis, vitiligo)
- Absence of supplementation with multivitamin supplements or vitamin D;
- Absence of chronic drug therapy with: anticonvulsants, antipsychotics, glucocorticoids, immunosuppressive corticosteroids, anti-retrovirals, slimming, hypocolestrolemicants, laxatives (prolonged use);
- acceptance and sign of informed consent.
Who cannot join
- Subjects under 18 years old;
- Affected by liver pathologies;
- Affected by kidney pathologies;
- Affected by intestinal malabsorption syndromes;
- Affected by cancer;
- Affected by primary hyperparathyroidism;
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- Affected by extensive dermatological pathologies (e.g. psoriasis, atopic dermatitis, vitiligo).
- Candidates and/or undergoing bariatric surgery;
- Supplementation with multivitamin or vitamin D;
- Chronic therapy with: anticonvulsants, antipsychotics, glucocorticoids, immunosuppressive corticosteroids, anti-retrovirals, slimming, hypocolestrolemizzanti, laxatives (prolonged use).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituti Clinici Scientifici Maugeri SpA
Pavia, Lombardy, 27100
Hellas Cena, +39 0382 987542, hellas.cena@unipv.it
Chiara Elena Tomasinelli, PhD
About this study
Since vitamin D deficiency is a condition that affects a high percentage of individuals of all ages and given the attention on the possible role of the deficiency of this vitamin in the development of various chronic diseases, including cardiovascular and metabolic disease (obesity, insulin resistance, hypertension, diabetes) and the correlation with mortality from major cardiovascular events (heart failure, myocardial infarction, sudden cardiac death, stroke, atrial fibrillation and peripheral vascular disease), it is clear that in clinical practice it is necessary to provide screening tools characterized by a simple use, high efficacy and a low economic impact, useful to detect a possible deficiency state that has a significant impact on general health and therefore provide targeted interventions for diagnosis and supplementation when and if necessary. Therefore, the objective of this study project is part of the broader context of supporting, with reproducible and shared scientific data, operational protocols useful for the clinician to identify subjects potentially at risk of vitamin D deficiency as well as directing to the diagnostic and more effective therapeutic. Surveillance of vitamin D status should be a high priority in which easy-to-use and interpreted tools, such as the questionnaire developed for this study, could respond to the needs of early identification of subjects potentially at risk of hypovitaminosis D, thus supporting the work of the clinician.
Read the detailed description
It will be administered the questionnaire which includes specific and previously identified questions useful for the purpose of the study to all patients who belong to the clinic of the Dietetics and Clinical Nutrition, Internal Medicine and Endocrinology Unit, ICS Maugeri di Pavia who meet the inclusion criteria and signed the Informed Consent. The blood dosage of 25 (OH) D will be used as a reference standard useful for achieving the purpose of the study subject to the execution of diagnostic-therapeutic procedures that are beneficial to the patient or performed for routine diagnostic procedures or previously prescribed by the general practitioner. The collected data will be entered in the Data Collected Form together with the laboratory tests.
Therefore, all patients will receive the EVIDENCE Questionnaire which includes 19 items that investigate those factors that influence the production, absorption and intake of vitamin D:
- anthropometric data (weight, height, waist circumference, BMI),
- demographic information, such as latitude and phototype,
- dietary intake of vitamin D,
- health status and therapies,
- multivitamin or vitamin D supplementation,
- sun exposure habits according to the season, frequency and time of exposure, the body parts exposed, the sunscreens use and outdoor activities.
The aim of the study is to develop a questionnaire useful in screening the adequacy of vitamin D concentration in the adult population and to produce evidence of construct validity and concurrent validity of the questionnaire itself.
SAMPLE SIZE: Psychometric literature suggests enrolling around 5-10 subjects for each item. Considering the number of items in the questionnaire, equal to 19, the number of subjects to be enrolled will be approximately 190.
- Conditions
- Vitamin D Deficiency, Vitamin D3 Deficiency, Vitamin D
- Keywords
- Vitamin D, Cholecalciferol, Deficiency, Inadeguacy, Screening, Questionnaire, Survey
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EvidenceQ Cohort | Adult subjects, aged over 18 years, male and female. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Construct validity (EVIDENCE Questionnaire)
The construct validity of the questionnaire will be assessed using exploratory factorial analysis.
Measured: 1 hour
Internal consistency (EVIDENCE Questionnaire)
The internal consistency will be evaluated with the Cronbach alpha coefficient or with the McDonald Omega coefficient.
Measured: 1 hour
Concurrent validity (EVIDENCE Questionnaire)
The concurrent validity will be assessed by comparing the results obtained with the serum 25 (OH) D dosage taken as the reference standard.
Measured: 1 hour
Questionnaire Scoring
Determine the optimal cut-off score of EvidenceQ for screening of subjects potentially at risk of vitamin D inadequacy.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start14 Jan 2020
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Jan 2022 (estimated)
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
- Cross-sectional
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA
- Responsible party
- Principal investigator, Hellas Cena, University of Pavia
- Investigators
- Hellas Cena, Principal investigator, Univeristy of Pavia, ICS Maugeri SpA SB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404842
- Sponsor's protocol ID
- 14052020
- Acronym
- EvidenceQ
- Status last verified
- May 2020
- First submitted
- 18 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Screening Tool for the Risk of Vitamin D Deficiency
- ClinicalTrials.gov ID
- NCT04404842
- Acronym / sponsor ID
- EvidenceQ / 14052020
- Conditions
- Vitamin D Deficiency, Vitamin D3 Deficiency, Vitamin D
- Keywords
- Vitamin D, Cholecalciferol, Deficiency, Inadeguacy, Screening, Questionnaire, Survey
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 28 May 2020 (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.
Since vitamin D deficiency is a condition that affects a high percentage of individuals of all ages and given the attention on the possible role of the deficiency of this vitamin in the development of various chronic diseases, including cardiovascular and metabolic disease (obesity, insulin resistance, hypertension, diabetes) and the correlation with mortality from major cardiovascular events (heart failure, myocardial infarction, sudden cardiac death, stroke, atrial fibrillation and peripheral vascular disease), it is clear that in clinical practice it is necessary to provide screening tools characterized by a simple use, high efficacy and a low economic impact, useful to detect a possible deficiency state that has a significant impact on general health and therefore provide targeted interventions for diagnosis and supplementation when and if necessary. Therefore, the objective of this study project is part of the broader context of supporting, with reproducible and shared scientific data, operational protocols useful for the clinician to identify subjects potentially at risk of vitamin D deficiency as well as directing to the diagnostic and more effective therapeutic. Surveillance of vitamin D status should be a high priority in which easy-to-use and interpreted tools, such as the questionnaire developed for this study, could respond to the needs of early identification of subjects potentially at risk of hypovitaminosis D, thus supporting the work of the clinician.
Detailed description
It will be administered the questionnaire which includes specific and previously identified questions useful for the purpose of the study to all patients who belong to the clinic of the Dietetics and Clinical Nutrition, Internal Medicine and Endocrinology Unit, ICS Maugeri di Pavia who meet the inclusion criteria and signed the Informed Consent. The blood dosage of 25 (OH) D will be used as a reference standard useful for achieving the purpose of the study subject to the execution of diagnostic-therapeutic procedures that are beneficial to the patient or performed for routine diagnostic procedures or previously prescribed by the general practitioner. The collected data will be entered in the Data Collected Form together with the laboratory tests.
Therefore, all patients will receive the EVIDENCE Questionnaire which includes 19 items that investigate those factors that influence the production, absorption and intake of vitamin D:
- anthropometric data (weight, height, waist circumference, BMI),
- demographic information, such as latitude and phototype,
- dietary intake of vitamin D,
- health status and therapies,
- multivitamin or vitamin D supplementation,
- sun exposure habits according to the season, frequency and time of exposure, the body parts exposed, the sunscreens use and outdoor activities.
The aim of the study is to develop a questionnaire useful in screening the adequacy of vitamin D concentration in the adult population and to produce evidence of construct validity and concurrent validity of the questionnaire itself.
SAMPLE SIZE: Psychometric literature suggests enrolling around 5-10 subjects for each item. Considering the number of items in the questionnaire, equal to 19, the number of subjects to be enrolled will be approximately 190.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EvidenceQ Cohort | – | –Adult subjects, aged over 18 years, male and female. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Psychometric literature suggests that about 5-10 subjects should be recruited for each item (Steiner DL et al, 2015). Considering the number of items in the questionnaire, equal to 19, the number of subjects to enlist will be about 190. Consecutively recruited adult patients by the Service of Dietetics and Clinical Nutrition, Unit of Internal Medicine and Endocrinology, of both sexes.
Key inclusion criteria (11 listed)
- Subjects older than or equal 18 years;
- Absence of liver pathologies;
- Absence of kidney pathologies;
- Absence of intestinal malabsorption syndromes;
- Absence of bariatric surgery;
Key exclusion criteria (10 listed)
- Subjects under 18 years old;
- Affected by liver pathologies;
- Affected by kidney pathologies;
- Affected by intestinal malabsorption syndromes;
- Affected by cancer;
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
Construct validity (EVIDENCE Questionnaire)
Time frame: 1 hour
The construct validity of the questionnaire will be assessed using exploratory factorial analysis.
Internal consistency (EVIDENCE Questionnaire)
Time frame: 1 hour
The internal consistency will be evaluated with the Cronbach alpha coefficient or with the McDonald Omega coefficient.
Concurrent validity (EVIDENCE Questionnaire)
Time frame: 1 hour
The concurrent validity will be assessed by comparing the results obtained with the serum 25 (OH) D dosage taken as the reference standard.
Questionnaire Scoring
Time frame: 1 hour
Determine the optimal cut-off score of EvidenceQ for screening of subjects potentially at risk of vitamin D inadequacy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
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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.
Hellas Cena principal investigator
Univeristy of Pavia, ICS Maugeri SpA SB
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 and Vitamin D3 Deficiency, run by University of Pavia at 1 site in Italy.
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 11 inclusion and 10 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 28 May 2020. 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 Italy. 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?
Contact Chiara Elena Tomasinelli (+39 0382 987536, chiara.tomasinelli@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Construct validity (EVIDENCE Questionnaire) (time frame: 1 hour). The study lists 4 primary outcomes in all. 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 28 May 2020.