Vitamin d DeficiencyNCT06098820
The Effect of UV-C Enriched Foods on Vitamin D Deficiency
A study testing Vitamin D status in people with Vitamin d Deficiency, run by Okan University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin d Deficiency
- What is being tested?
- Vitamin D status
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2023to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Not being in a solarium
- Not eating fish more than once a week
- Volunteering to participate in the research
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Vitamin d Deficiency
- Being tested
- Vitamin D status
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D statusOther
Four different groups will be compared with each other in terms of vitamin D effect.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (UV-C mushroom+normal bread group) | Experimental | UV-C mushroom+normal bread group Receives: Other: Vitamin D status |
| Group 2 (UV-C mushroom + UV-C bread group) | Experimental | UV-C mushroom + UV-C bread group Receives: Other: Vitamin D status |
| Group 3 (normal mushroom + normal bread group) | Experimental | normal mushroom + normal bread group Receives: Other: Vitamin D status |
| Group 4 (normal mushroom+normal bread+supplemente group) | Experimental | normal mushroom + normal bread + supplement group Receives: Other: Vitamin D status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D values
During study, Vitamin D values are evaluated.
Measured: 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.
Measured: 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.
Measured: Pre-intervention
Food consumption record
Before starting the study and after the end of study the food consumption of participants are evaluated.
Measured: Pre-intervention, through study completion, an average of every two weeks and 1 month after the completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start5 Mar 2023
- Primary completion31 May 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin d DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Collaborators
- Arçelik A.Ş.
- Responsible party
- Principal investigator, Aylin Seylam Küşümler, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098820
- Sponsor's protocol ID
- 2013
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Consumption of UV-C Enriched Foods on Biochemical Findings in Adults With Vitamin D Deficiency
- ClinicalTrials.gov ID
- NCT06098820
- Acronym / sponsor ID
- 2013
- Conditions
- Vitamin d Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Collaborators
- Arçelik A.Ş.
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- 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)
| Arm | Type | Receives |
|---|---|---|
| Group 1 (UV-C mushroom+normal bread group) | Experimental | Other: Vitamin D statusUV-C mushroom+normal bread group |
| Group 2 (UV-C mushroom + UV-C bread group) | Experimental | Other: Vitamin D statusUV-C mushroom + UV-C bread group |
| Group 3 (normal mushroom + normal bread group) | Experimental | Other: Vitamin D statusnormal mushroom + normal bread group |
| Group 4 (normal mushroom+normal bread+supplemente group) | Experimental | Other: Vitamin D statusnormal mushroom + normal bread + supplement group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D statusFour different groups will be compared with each other in terms of vitamin D effect. | Other | 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) |
Primary outcome
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.
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.
Demographic parameters
Time frame: Pre-intervention
Demographic values (age, gender, etc.) are also investigated.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D status in people with Vitamin d Deficiency, run by Okan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.