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

Primary Purpose

Vitamin d Deficiency

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Vitamin D status
Sponsored by
Okan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Vitamin d Deficiency

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

Sites / Locations

  • OkanU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

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+supplemente group)

Arm Description

UV-C mushroom+normal bread group

UV-C mushroom + UV-C bread group

normal mushroom + normal bread group

normal mushroom + normal bread + supplement group

Outcomes

Primary Outcome Measures

Vitamin D values
During study, Vitamin D values are evaluated.
Biochemical parameters
Ca and parathormone are evaluated during the study.
Demographic parameters
Demographic values (age, gender, etc.) are also investigated.
Food consumption record
Before starting the study and after the end of study the food consumption of participants are evaluated.

Secondary Outcome Measures

Full Information

First Posted
October 13, 2023
Last Updated
October 23, 2023
Sponsor
Okan University
Collaborators
Arçelik A.Ş.
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1. Study Identification

Unique Protocol Identification Number
NCT06098820
Brief Title
The Effect of UV-C Enriched Foods on Vitamin D Deficiency
Official Title
The Effect of Consumption of UV-C Enriched Foods on Biochemical Findings in Adults With Vitamin D Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 5, 2023 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
August 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Okan University
Collaborators
Arçelik A.Ş.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin d Deficiency

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (UV-C mushroom+normal bread group)
Arm Type
Experimental
Arm Description
UV-C mushroom+normal bread group
Arm Title
Group 2 (UV-C mushroom + UV-C bread group)
Arm Type
Experimental
Arm Description
UV-C mushroom + UV-C bread group
Arm Title
Group 3 (normal mushroom + normal bread group)
Arm Type
Experimental
Arm Description
normal mushroom + normal bread group
Arm Title
Group 4 (normal mushroom+normal bread+supplemente group)
Arm Type
Experimental
Arm Description
normal mushroom + normal bread + supplement group
Intervention Type
Other
Intervention Name(s)
Vitamin D status
Intervention Description
Four different groups will be compared with each other in terms of vitamin D effect.
Primary Outcome Measure Information:
Title
Vitamin D values
Description
During study, Vitamin D values are evaluated.
Time Frame
Pre-intervention, through study completion, an average of every two weeks and 1 month after the completion of the intervention
Title
Biochemical parameters
Description
Ca and parathormone are evaluated during the study.
Time Frame
Pre-intervention, through study completion, an average of every two weeks and 1 month after the completion of the intervention
Title
Demographic parameters
Description
Demographic values (age, gender, etc.) are also investigated.
Time Frame
Pre-intervention
Title
Food consumption record
Description
Before starting the study and after the end of study the food consumption of participants are evaluated.
Time Frame
Pre-intervention, through study completion, an average of every two weeks and 1 month after the completion of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
Facility Information:
Facility Name
OkanU
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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