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

October 23, 2023 updated by: Aylin Seylam Küşümler, Okan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • OkanU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamin D values
Time Frame: 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.
Pre-intervention, through study completion, an average of every two weeks and 1 month after the completion of the intervention
Biochemical parameters
Time Frame: 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.
Pre-intervention, through study completion, an average of every two weeks and 1 month after the completion of the intervention
Demographic parameters
Time Frame: Pre-intervention
Demographic values (age, gender, etc.) are also investigated.
Pre-intervention
Food consumption record
Time Frame: 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.
Pre-intervention, through study completion, an average of every two weeks and 1 month after the completion of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Okan University

Collaborators

Arçelik A.Ş.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2023

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

October 23, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013 (Other Grant/Funding Number: Food Innovation Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitamin d Deficiency

Clinical Trials on Vitamin D status

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe