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IRCT20250115064387N1 IRCT 2025-04-17 Kerman University of Medical Sciences Studying the effect of consuming functional tomato paste enriched with vitamin D3 Studying the effect of consuming functional tomato paste enriched with vitamin D3 on serum levels in adults aged 20-60 years 2025-04-19 anticipated 100 Complete https://irct.ir/trial/81381 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, 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. N/A Vitamin D3 deficiency. Intervention Group: Consumption of vitamin D-fortified tomato paste.•. Yes - There is a plan to make this available What will be shared: Undecided - It is not yet known if there will be a plan to make this available When: Twelve months later. To whom: It is not yet known if there will be a plan to make this available Conditions: It is not yet known if there will be a plan to make this available Where to obtain: It is not yet known if there will be a plan to make this available How to obtain: It is not yet known if there will be a plan to make this available Comments: I have no comments.
public Dr. Ehsan Sadeghi
Kermanshah Province, Kermanshah City, Eythar Square, next to Farabi Hospital, Faculty of Nutrition and Food Industries.
kermanshah Iran (Islamic Republic of) 6719851552 +98 83 3710 2002 Nfst_school@kums.ac.ir Kermanshah University of Medical Sciences scientific Dr. Ehsan Sadeghi
Kermanshah Province, Kermanshah City, Eythar Square, next to Farabi Hospital, Faculty of Nutrition and Food Industries.
kermanshah Iran (Islamic Republic of) 6719851552 +98 83 3710 2002 Nfst_school@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) 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. 20 years 60 years Both 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. Prevention Intervention Group: Consumption of vitamin D-fortified tomato paste.• 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. Kerman University of Medical Sciences Approved 2025-01-01 The Ethics Committee of Kermanshah University of Medical Sciences Kermanshah - Shahid Beheshti Boulevard - Central Building of Kermanshah University of Medical Sciences. kermanshah Kermanshah Iran (Islamic Republic of)