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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06098820
Other study ID # 2013
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 5, 2023
Est. completion date August 31, 2023

Study information

Verified date October 2023
Source Okan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is an experimental design study in which demographic characteristics, food consumption, biochemical parameters and anthropometric measurements of individuals with low vitamin D levels before and after consuming UV-enriched foods will be examined.


Description:

It was designed to be applied to individuals with low vitamin D levels working in Fatih Sultan Mehmet Training and Research Hospital who meet the research conditions. n the first phase of the study, demographic information will be recorded by asking demographic information from the people who volunteered to participate in the study and who meet the study criteria by using a questionnaire form and 3-day food consumption record information by face-to-face interview technique; anthropometric measurements of the participants will be taken and baseline blood values will be recorded. At the beginning of the experimental study, individuals will be randomized by computer-assisted randomization into four different groups. Biochemical analyses will be analyzed every two weeks, analyses will be repeated 1 month after the study and the effects of vitamin D enrichment on biochemical parameters will be determined.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date August 31, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Working in the hospital 2. Being between the ages of 18 and 65 3. Not being pregnant or lactating 4. Not taking vitamin D supplements or fish oil in the last 1 month 5. Serum 25(OH)vitamin D value below 30 µg/L 6. No kidney disease, kidney stones, cortisone use, blood thinners 7. Not being in a solarium 8. Not eating fish more than once a week 9. Volunteering to participate in the research Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Vitamin D status
Four different groups will be compared with each other in terms of vitamin D effect.

Locations

Country Name City State
Turkey OkanU Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Okan University Arçelik A.S.

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Vitamin D values During study, Vitamin D values are evaluated. Pre-intervention, through study completion, an average of every two weeks and 1 month after the completion of the intervention
Primary Biochemical parameters Ca and parathormone are evaluated during the study. Pre-intervention, through study completion, an average of every two weeks and 1 month after the completion of the intervention
Primary Demographic parameters Demographic values (age, gender, etc.) are also investigated. Pre-intervention
Primary Food consumption record Before starting the study and after the end of study the food consumption of participants are evaluated. Pre-intervention, through study completion, an average of every two weeks and 1 month after the completion of the intervention
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