The Effect of UV-C Enriched Foods on Vitamin D Deficiency

Sponsor

Okan University (Other)

Overall Status

Completed

CT.gov ID

NCT06098820

Collaborator

Arçelik A.Ş. (Other)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin d Deficiency	Other: Vitamin D status	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Forty-eight people aged 18-65 years with serum 25(OH)vitamin D levels below 30 μg/L and who meet the study criteria will be selected for the study. Four groups, 12 per group, will be randomly selected by computer-assisted randomization. Group 1 (UV-C mushroom+normal bread group): Group 2 (UV-C mushroom + UV-C bread group) Group 3 (normal mushroom + normal bread group) Group 4 (normal mushroom + normal bread + supplement group)Forty-eight people aged 18-65 years with serum 25(OH)vitamin D levels below 30 μg/L and who meet the study criteria will be selected for the study. Four groups, 12 per group, will be randomly selected by computer-assisted randomization.Group 1 (UV-C mushroom+normal bread group):Group 2 (UV-C mushroom + UV-C bread group) Group 3 (normal mushroom + normal bread group) Group 4 (normal mushroom + normal bread + supplement group)

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Screening

Official Title:

The Effect of Consumption of UV-C Enriched Foods on Biochemical Findings in Adults With Vitamin D Deficiency

Actual Study Start Date :

Mar 5, 2023

Actual Primary Completion Date :

May 31, 2023

Actual Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 (UV-C mushroom+normal bread group) UV-C mushroom+normal bread group	Other: Vitamin D status Four different groups will be compared with each other in terms of vitamin D effect.
Experimental: Group 2 (UV-C mushroom + UV-C bread group) UV-C mushroom + UV-C bread group	Other: Vitamin D status Four different groups will be compared with each other in terms of vitamin D effect.
Experimental: Group 3 (normal mushroom + normal bread group) normal mushroom + normal bread group	Other: Vitamin D status Four different groups will be compared with each other in terms of vitamin D effect.
Experimental: Group 4 (normal mushroom+normal bread+supplemente group) normal mushroom + normal bread + supplement group	Other: Vitamin D status Four different groups will be compared with each other in terms of vitamin D effect.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Working in the hospital
Being between the ages of 18 and 65
Not being pregnant or lactating
Not taking vitamin D supplements or fish oil in the last 1 month
Serum 25(OH)vitamin D value below 30 μg/L
No kidney disease, kidney stones, cortisone use, blood thinners
Not being in a solarium
Not eating fish more than once a week
Volunteering to participate in the research

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OkanU	Istanbul		Turkey

Sponsors and Collaborators

Okan University
Arçelik A.Ş.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aylin Seylam Küşümler, Assistant Professor, Okan University

ClinicalTrials.gov Identifier:

NCT06098820

Other Study ID Numbers:

2013

First Posted:

Oct 25, 2023

Last Update Posted:

Oct 25, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Vitamin D Deficiency

Vitamin D

Study Results

No Results Posted as of Oct 25, 2023