1- Determining the effect of consuming natural gum enriched with vitamin D3 on serum 25(OH)D levels in students of the Faculty of Health, Qazvin University of Medical Sciences
2- Determining the effect of consuming natural gum enriched with vitamin D3 on serum calcium levels
3- Determining the effect of consuming natural gum enriched with vitamin D3 on serum phosphorus levels
4- Determining the effect of consuming natural gum enriched with vitamin D3 on serum PTH hormone levels
5- If possible, producing natural gum enriched with vitamin D3
Design
A two-group clinical trial in which one group received natural gum enriched with vitamin D3 and the other group received vitamin D3 tablets, single-blinded because it is not known which patient may be placed in the gum or drug group, randomized with allocation software.
Settings and conduct
Sampling and isolating individuals with low serum 25OH D levels, then randomizing and donating pills or gum to groups, and taking blood after one month of use.
Participants/Inclusion and exclusion criteria
Inclusion criteria: No underlying disease (diabetes, autoimmune diseases), kidney and cardiovascular diseases and insufficiency, digestive diseases and indigestion, no use of vitamin D supplements, no use of alcohol and drugs, use of drugs involved in fat absorption. Exclusion criteria: No continuation of the intervention due to illness or special events.
Intervention groups
Group receiving natural gum enriched with vitamin D3
Group receiving vitamin D3 tablets
Main outcome variables
Consumption of natural gum enriched with vitamin D3 affects serum levels of 25(OH)D.
Consumption of natural gum enriched with vitamin D3 affects serum levels of calcium.
Consumption of natural gum enriched with vitamin D3 affects serum levels of phosphorus.
Consumption of natural gum enriched with vitamin D3 affects serum levels of PTH hormone.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251027067781N1
Registration date:2025-11-26, 1404/09/05
Registration timing:registered_while_recruiting
Last update:2025-11-26, 1404/09/05
Update count:0
Registration date
2025-11-26, 1404/09/05
Registrant information
Name
Arvin Shajeie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 2653
Email address
a.shajeie@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-22, 1404/09/01
Expected recruitment end date
2025-12-21, 1404/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of vitamin D3-fortified natural chewing gum's impact on students' serum 25(OH)D levels.
Public title
Evaluation of the effect of consuming natural chewing gum fortified by vitamin D3 compared to vitamin D3 tablets
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Insufficient serum vitamin D3 levels
Not pregnant
No underlying disease (diabetes, autoimmune diseases)
Kidney and cardiovascular diseases and failures
Not taking vitamin D supplements
Abstaining from alcohol and drugs
Taking medications that affect fat absorption
Exclusion criteria:
pregnancy
Taking vitamin D supplements
Alcohol consumption
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation of samples to two groups is done based on block random allocation. In this way, the sequence of samples will be determined with the help of Random Allocation Software Version 1.0.0.
In order to conceal the random allocation process, the names of the groups will be placed in envelopes and these envelopes will be numbered and arranged in a box.
The samples will be placed in one of the study groups in order according to the contents of the envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2025-03-08, 1403/12/18
Ethics committee reference number
IR.QUMS.REC.1403.492
Health conditions studied
1
Description of health condition studied
Vitamin D3 deficiency
ICD-10 code
E55.9
ICD-10 code description
Vitamin D deficiency, unspecified
Primary outcomes
1
Description
25(OH)D serum level
Timepoint
Before the start of the study and 14 and 30 days after starting to take the tablets and gum
Method of measurement
Testing of collected serum samples using ELISA method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Consumer of chewing gum enriched with vitamin D3
Category
Treatment - Other
2
Description
Control group: Vitamin D3 tablet user
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin University of Medical Sciences
Full name of responsible person
Arvin Shajeie
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3335 2653
Fax
+98 28 3335 5162
Email
a.shajeie@gmail.com
Web page address
https://qums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jiran Darou
Full name of responsible person
Weria Naseri
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3335 2653
Fax
+98 28 3335 5162
Email
a.shajeie@gmail.com
Web page address
https://qums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Jiran Darou company
Proportion provided by this source
30
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Razagh Mahmoudi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Food safety and Health
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin,
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3335 2653
Fax
+98 28 3335 5162
Email
r.mahmodi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Razagh Mahmoudi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Food safety and Health
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 34 1975 9811
Fax
+98 28 3335 5162
Email
r.mahmodi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Arvin Shajeie
Position
Student
Latest degree
Master
Other areas of specialty/work
Food safety and Health
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 918 380 3601
Email
a.shajeie@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It is for clinical study only.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available