The effect of consuming tomato paste enriched with vitamin D3
Design
This study is a single-arm trial and will examine the effect of consuming tomato paste enriched with 25-hydroxyvitamin D3 on the serum levels of 100 volunteers aged 20 to 60 years with appropriate eligibility criteria such as not having severe vitamin D deficiency and individuals with a BMI less than 30).
Settings and conduct
The study will be conducted in an appropriate setting, such as a research clinic or health center, to facilitate blood sampling and ensure close monitoring of participants.
Nutritional Control:
Ensuring participants consume a specified daily amount of tomato paste. This can be controlled by providing pre-measured packets to participants and recording the amount consumed.
Monitoring and Supervision:
The research team will include nutrition specialists, physicians, and laboratory technicians.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age between 20 and 60 years, Participants should not have chronic diseases,
Participants should have low or normal serum vitamin D levels, but not higher than the optimal level, Participants should not have taken vitamin D supplements in the past 3 months, Consent to participate in the study
Exclusion Criteria:
Failure to consume vitamin D2-fortified food products, Failure to comply with the study conditions prescribed tomato paste, worsening of underlying diseases that affect the continuation of the study, Allergic reaction, Participant's decision to withdraw from the study at any stage.
Intervention groups
Consumption of vitamin D-fortified tomato paste
Main outcome variables
The concentration of vitamin D3 in the paste will remain constant.
The rheological properties will not change.
The sensory acceptance will not change.
The concentration of vitamin D3 in the blood serum of the subjects will increase.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250115064387N1
Registration date:2025-04-17, 1404/01/28
Registration timing:prospective
Last update:2025-04-17, 1404/01/28
Update count:0
Registration date
2025-04-17, 1404/01/28
Registrant information
Name
Ehsan Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 918 836 5313
Email address
e.sadeghi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-19, 1404/01/30
Expected recruitment end date
2026-04-19, 1405/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of consuming functional tomato paste enriched with vitamin D3 on serum levels in adults aged 20-60 years
Public title
Studying the effect of consuming functional tomato paste enriched with vitamin D3
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The age of the participants should be between 20 and 60 years.
The participants should not have chronic diseases.
The participants should not have certain bone diseases such as severe osteoporosis.
The participants' serum vitamin D levels should be low or within the normal range, but not higher than the optimal level.
The participants should not have taken vitamin D supplements in the past 3 months.
Consent to participate in the study should be obtained from the participants.
Exclusion criteria:
If the study conditions are not met by individuals.
Inclusion of any additional intervention that affects serum vitamin D levels.
Allergic reaction or intolerance to the ingredients in enriched tomato paste.
Participant's decision to withdraw from the study at any stage.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
The informed consent form will be provided to the participants, and upon obtaining their consent, they will be evaluated based on the factors outlined in the study.Data collection will be conducted by colleagues and based on the results of laboratory tests and questionnaires. Participant visits will take place in a location where blood sampling and thorough follow-up of participants can be performed, such as a clinic.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Kermanshah University of Medical Sciences
Street address
Kermanshah - Shahid Beheshti Boulevard - Central Building of Kermanshah University of Medical Sciences.
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2025-01-01, 1403/10/12
Ethics committee reference number
50005142
Health conditions studied
1
Description of health condition studied
Vitamin D3 deficiency
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Change in Serum Vitamin D Levels:The change in serum 25-hydroxy vitamin D concentration between the beginning of the study and the end of the intervention period.This is the primary indicator of vitamin D status in the body and directly reflects the effect of the intervention.
Timepoint
Four months
Method of measurement
In this study, the effect of consuming tomato paste enriched with vitamin D3 on the serum levels of 100 volunteers aged 20 to 60 years with appropriate eligibility criteria such as not having severe vitamin D deficiency and people with a BMI less than 30 will be investigated. These people will consume the product for 4 months. It is possible to obtain 800 to 1000 units of vitamin D through foods fortified with this vitamin. In order to obtain this amount of vitamin and in accordance with the amount of vitamin D added to the product, it is considered to consume 100 grams of tomato paste per day. Finally, changes in serum vitamin D levels in people will be determined using a blood test.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Consumption of vitamin D-fortified tomato paste.•
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Kermanshah
Full name of responsible person
Dr. Ehsan Sadeghi.
Street address
Kermanshah - End of Parastar Boulevard - Next to the Faculty of Medicine.
City
kermanshah
Province
Kermanshah
Postal code
5333 - 767427
Phone
+98 83 3427 6300
Fax
+98 83 3427 6300
Email
irhk @ kums.ac.ir
Web page address
https://imamreza.kums.ac.ir/fa/sitemap
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Zohra Rahimi
Street address
Kermanshah - Shahid Beheshti Boulevard - Central Building of Kermanshah University of Medical Sciences.
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3838 4185
Fax
+98 83 3838 6835
Email
research_it@kums.ac.ir
Web page address
https://vc-research.kums.ac.ir/
Grant name
Grant code / Reference number
50005142
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Ehsan Sadeghi
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Food safety and Health
Street address
Kermanshah Province, Kermanshah City, Eythar Square, next to Farabi Hospital, Faculty of Nutrition and Food Industries.
City
kermanshah
Province
Kermanshah
Postal code
6719851552
Phone
+98 83 3710 2002
Fax
+98 83 3710 2002
Email
Nfst_school@kums.ac.ir
Web page address
https://nsft-school.kums.ac.ir/fa/contactus
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Ehsan Sadeghi
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Food safety and Health
Street address
Kermanshah Province, Kermanshah City, Eythar Square, next to Farabi Hospital, Faculty of Nutrition and Food Industries.
City
kermanshah
Province
Kermanshah
Postal code
6719851552
Phone
+98 83 3710 2002
Fax
+98 83 3710 2002
Email
Nfst_school@kums.ac.ir
Web page address
https://nsft-school.kums.ac.ir/fa/contactus
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Ahsan Sadeghi
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Food safety and Health
Street address
Kermanshah Province, Kermanshah City, Eythar Square, next to Farabi Hospital, Faculty of Nutrition and Food Industries.
City
kermanshah
Province
Kermanshah
Postal code
6719851552
Phone
+98 83 3710 2002
Fax
+98 83 3710 2002
Email
ehsan.sadeghi59@yahoo.com
Web page address
https://nsft-school.kums.ac.ir/fa/contactus
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Undecided - It is not yet known if there will be a plan to make this available
When the data will become available and for how long
Twelve months later.
To whom data/document is available
It is not yet known if there will be a plan to make this available
Under which criteria data/document could be used
It is not yet known if there will be a plan to make this available
From where data/document is obtainable
It is not yet known if there will be a plan to make this available
What processes are involved for a request to access data/document
It is not yet known if there will be a plan to make this available