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

NCT06098820 | Completed

• 1 other identifier: 2013
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin d Deficiency

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Demographic parameters

  Demographic values (age, gender, etc.) are also investigated.

  Pre-intervention

• 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

Study Arms (4)

Group 1 (UV-C mushroom+normal bread group)

EXPERIMENTAL

UV-C mushroom+normal bread group

Other: Vitamin D status

Group 2 (UV-C mushroom + UV-C bread group)

EXPERIMENTAL

UV-C mushroom + UV-C bread group

Other: Vitamin D status

Group 3 (normal mushroom + normal bread group)

EXPERIMENTAL

normal mushroom + normal bread group

Other: Vitamin D status

Group 4 (normal mushroom+normal bread+supplemente group)

EXPERIMENTAL

normal mushroom + normal bread + supplement group

Other: Vitamin D status

Interventions

Vitamin D status OTHER

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

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)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Okan University: lead
• Arçelik A.Ş.: collaborator

Study Sites (1)

OkanU

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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)

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 25, 2023
• Study Start: March 5, 2023
• Primary Completion: May 31, 2023
• Study Completion: August 31, 2023
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)