Vitamin D Deficiency Clinical Trial
— EvidenceQOfficial title:
Development of a Screening Tool for the Risk of Vitamin D Deficiency
NCT number | NCT04404842 |
Other study ID # | 14052020 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 14, 2020 |
Est. completion date | January 31, 2022 |
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.
Status | Recruiting |
Enrollment | 190 |
Est. completion date | January 31, 2022 |
Est. primary completion date | January 31, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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; - 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. Exclusion Criteria: - 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; - 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). |
Country | Name | City | State |
---|---|---|---|
Italy | Istituti Clinici Scientifici Maugeri SpA | Pavia | Lombardia |
Lead Sponsor | Collaborator |
---|---|
University of Pavia | Istituti Clinici Scientifici Maugeri SpA |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Construct validity (EVIDENCE Questionnaire) | The construct validity of the questionnaire will be assessed using exploratory factorial analysis. | 1 hour | |
Primary | Internal consistency (EVIDENCE Questionnaire) | The internal consistency will be evaluated with the Cronbach alpha coefficient or with the McDonald Omega coefficient. | 1 hour | |
Primary | 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. | 1 hour | |
Primary | Questionnaire Scoring | Determine the optimal cut-off score of EvidenceQ for screening of subjects potentially at risk of vitamin D inadequacy. | 1 hour |
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