Development of a Screening Tool for the Risk of Vitamin D Deficiency

NCT04404842 | Unknown

• 1 other identifier: 14052020
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Vitamin D Deficiency; Vitamin D3 Deficiency; Vitamin D

Keywords

Vitamin D; Cholecalciferol; Deficiency; Inadeguacy; Screening; Questionnaire; Survey

Outcome Measures

Primary Outcomes (4)

• Construct validity (EVIDENCE Questionnaire)

  The construct validity of the questionnaire will be assessed using exploratory factorial analysis.

  1 hour

• Internal consistency (EVIDENCE Questionnaire)

  The internal consistency will be evaluated with the Cronbach alpha coefficient or with the McDonald Omega coefficient.

  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.

  1 hour

• Questionnaire Scoring

  Determine the optimal cut-off score of EvidenceQ for screening of subjects potentially at risk of vitamin D inadequacy.

  1 hour

Study Arms (1)

EvidenceQ Cohort

Adult subjects, aged over 18 years, male and female.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Pavia: lead
• Istituti Clinici Scientifici Maugeri SpA: collaborator

Study Sites (1)

Istituti Clinici Scientifici Maugeri SpA

Pavia, Lombardy, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

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

Study Officials

• Hellas Cena

  Univeristy of Pavia, ICS Maugeri SpA SB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiara Elena Tomasinelli

CONTACT

+39 0382 987536; chiara.tomasinelli@unipv.it

Hellas Cena

CONTACT

0382 987542; hellas.cena@unipv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tenured researcher

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 28, 2020
• Study Start: January 14, 2020
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: May 28, 2020

Record last verified: 2020-05

Locations

IT (1)