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IRCT20101130005280N27 IRCT 2019-03-09 National Institute for Medical Research Development Evaluation of vitamin D efficacy on biochemical markers Evaluation of the efficacy of low-fat dairy products fortified with encapsulated vitamin D on on biochemical markers of liver, kidney and cardiovascular system functions 2018-12-21 anticipated 280 Complete https://irct.ir/trial/35869 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: 280 adults were divided into two groups of intervention and two control groups through stratified block randomization by using the numbered, sealed and stapled envelopes, Blinding description: According to the double-blind study, blinding is done for participants and researchers for the intervention and control group. The intervention and control groups are quite similar in terms of appearance, taste and smell and only intervention groups will contain 1,500 international units of nano encapsulated vitamin D. 3 Vitamin D Deficiency. Intervention 1: First control group: 70 adults receive 200 ml of daily non-fortified milk for 2.5 months. Intervention 2: Intervention group: 70 adults receive 200 ml daily milk fortified with encapsulated vitamin D (1500 IU), for 2.5 months. Intervention 3: Second control group: 70 adults receive 100 ml of daily non-fortified yogurt for 2.5 months. Intervention 4: Intervention group: 70 adults receive 100 ml daily yogurt fortified with encapsulated vitamin D (1500 IU), for 2.5 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The definite publication program plan will be announced after update completion.
public Payam Sharifan
Faculty of Medicine, Azadi Sq.
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3882 9260 Sharifanp961@mums.ac.ir Mashhad University of Medical Sciences scientific Majid Ghayour-Mobarhan
Faculty of Medicine, Azadi Sq.
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3882 9260 ghayourm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) aged between 18 to 65 having full consent for participation in trial 18 years 65 years Both not taking any vitamin D supplement in the last three months before the trial not having Chronic Liver Diseases, Cystic Fibrosis, Crohn's, and Sprue Lifestyle Lifestyle Lifestyle Lifestyle First control group: 70 adults receive 200 ml of daily non-fortified milk for 2.5 months Intervention group: 70 adults receive 200 ml daily milk fortified with encapsulated vitamin D (1500 IU), for 2.5 months. Second control group: 70 adults receive 100 ml of daily non-fortified yogurt for 2.5 months. Intervention group: 70 adults receive 100 ml daily yogurt fortified with encapsulated vitamin D (1500 IU), for 2.5 months. Bone Density. Timepoint: Baseline, 75th day. Method of measurement: BMD Method. Anthropometric factors. Timepoint: Baseline, 75th day. Method of measurement: using standard scales for weight and height measurement. Blood pressure. Timepoint: Baseline, 75th day. Method of measurement: Systolic and diastolic blood pressure measurement. Depression. Timepoint: Baseline, 75th day. Method of measurement: Beck depression assessment. Eating habits. Timepoint: baseline. Method of measurement: FFQ. Biochemical state. Timepoint: Baseline, 75th day. Method of measurement: Blood test. National Institute for Medical Research Development Approved 2017-07-15 Ethics committee of National Institute for Medical Research Development National Institute for Medical Research Development, No 21, Besat Ave, West Dr. Fatemi Ave Tehran Tehran Iran (Islamic Republic of)