Development of a Screening Tool for the Risk of Vitamin D Deficiency
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Vitamin D
- Vitamin D Deficiency
- Vitamin D3 Deficiency
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Cross-Sectional
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 incl...
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.
Tracking Information
- NCT #
- NCT04404842
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA
- Investigators
- Principal Investigator: Hellas Cena Univeristy of Pavia, ICS Maugeri SpA SB