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IRCT20180708040401N1 IRCT 2018-10-04 Shiraz University of Medical Sciences Fortification and supplementation effect on vitamin D levels Comparison of the effects of vitamin D fortified oil and vitamin D supplement in improving vitamin D status and bone turnover factors among 18-30 healthy persons. 2018-08-23 anticipated 99 Complete https://irct.ir/trial/32793 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization by random digits table: participants are numbered from 1 to 99, then a row and a column of the random digits table are chosen randomly, the place of intersection of the row and the column is considered as the beginning point. We move our hand continuously on the table, the first number which the last two digits are the number of one of participants, is placed in the first group, the second number in the second group, the third number in the third group; and we go on to dedicate 33 participants in each group, Blinding description: Someone who is not participating in the study, grouped oils and pills, then delivered them to the researcher so all individuals involved in the study are blind. Placebo pills are quite similar to vitamin D pills (produced by the same company). Fortified oil are also completely the same as unfortified oil in terms of color and packaging. 3 Healthy people. Intervention 1: Intervention group: a supplement tablet containing 1000 IU vitamin D per day + 25 gram ordinary canola oil. Intervention 2: Intervention group: a placebo tablet + 25 gram canola oil enriched by 1000 IU vitamin D per day. Intervention 3: Control group: a placebo tablet + 25 gram ordinary canola oil. Yes - There is a plan to make this available What will be shared: Data file, information related to main variable will be shared. The study protocol is fully be shared. I will share the informed consent forms. When: first accessibility after submitting the article. To whom: Data will be available to academic researchers. Conditions: I have not decided yet. Where to obtain: Doctor Shiva Faghih: shivafaghih@gamail.com How to obtain: After posting the email, his request is checked and, if the criteria are met, the data will be sent to him. Comments:
public Shiva Faghih
Nutrition and food science faculty, opposite of Bargh club, Razi Blvd
Shiraz Iran (Islamic Republic of) 71536-75541 +98 71 3725 1001 Sh_faghih@sums.ac.ir Shiraz University of Medical Sciences scientific Shiva Faghih
Nutrition and food science faculty, opposite of Bargh club, Razi Blvd
Shiraz Iran (Islamic Republic of) 71536-75541 +98 71 3725 1001 Sh_faghih@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) 18-30 years old The absence of diseases which influence the metabolism of Ca, P and vitamin D such as thyroid and parathyroid disorders, chronic kidney disease, osteoporosis, or bone fractures caused by osteoporosis, during the past year The absence of cardiovascular disease, diabetes, chronic digestive diseases, hepatitis and cancer No medical treatment for osteoporosis or other bone diseases in the last 6 months, such as taking Bisphosphonates, Raloxifene, Teriparatide and Denosambe Not using Glucocorticoids Not using nutritional supplements No pregnancy and lactation Not participating in other studies in the last 6 months 18 years 30 years Both The presence of diseases affecting the metabolism of phosphorus, calcium and vitamin D The presence of cardiovascular disease, diabetes, chronic diseases of the digestive tract, hepatitis and cancer Medical treatment for osteoporosis or other bone diseases in the last 6 months Treatment with glucocorticoids Using nutritional supplements Pregnancy and lactating Participating in other studies in the last 6 months Treatment - Drugs Treatment - Drugs Placebo Intervention group: a supplement tablet containing 1000 IU vitamin D per day + 25 gram ordinary canola oil Intervention group: a placebo tablet + 25 gram canola oil enriched by 1000 IU vitamin D per day Control group: a placebo tablet + 25 gram ordinary canola oil 25-hydroxy vitamin D. Timepoint: Beginning of the study (before starting intervention), at the end of the study (after the end of intervention). Method of measurement: Enzyme-linked immunosorbent assay (ELISA). Parathyroid hormone. Timepoint: Beginning of the study (before starting intervention), at the end of the study (after the end of intervention). Method of measurement: Enzyme-linked immunosorbent assay (ELISA). Bone specific alkalin phosphatase. Timepoint: Beginning of the study (before starting intervention), at the end of the study (after the end of intervention). Method of measurement: Spectophotometric assay. Collagen type 1 cross-linked C-telopeptide I(CTX-I). Timepoint: Beginning of the study (before starting intervention), at the end of the study (after the end of intervention). Method of measurement: Enzyme-linked immunosorbent assay (ELISA). Shiraz University of Medical Sciences Approved 2017-11-05 Ethics committee of Shiraz University of Medical Science Central Building of Shiraz University of Medical Sciences-opposite Palestin Street-Zand Avenue Shiraz Fars Iran (Islamic Republic of)