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IRCT20230416057916N1 IRCT 2023-11-20 Shiraz University of Medical Sciences Determination the effect of calcium and vitamin B12 co-supplementation on some anthropometric indices, blood glucose, lipid profile and blood pressure in Individuals with metabolic syndrome Determination the effect of calcium and vitamin B12 co-supplementation on some anthropometric indices, blood glucose, lipid profile and blood pressure in Individuals with metabolic syndrome: a randomized triple-blind controlled clinical trial 2023-12-02 anticipated 56 Complete https://irct.ir/trial/72805 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will perform using the random block method (1: 1 ratio) for 2 groups ( intervention and control groups). In this method, blocks of two with rotation will be created by an out-of-study person. Then, a block will be randomly selected to determine the groups assigned to the first two participants. The random-blocks selection process will be repeated to determine the random allocation for the entire sample size. For allocation concealment, after determining the random sequence, these sequences will be placed in numbered sealed opaqued envelopes for each participant. An out-of-study person familiar with randomization will perform this process. During the study, by entering any participant in the study, based on the sequence, an envelope will be opened and the allocated group will be revealed, Blinding description: After determining the random allocation sequence, groups are named A and B based on the assigned names A and B in order and according to the sequence specified in the packets by the person outside the study. Then, based on the assigned blocks, supplements are provided to the participants. Participants are unaware of their assignment to the supplement or placebo group. After collecting the data, the results of the outcomes are analyzed based on groups A and B. 3 Metabolic syndrome. Intervention 1: Intervention group: In this group, individuals will receive 500 mg of calcium carbonate supplement and 500 mcg of cyanocobalamin (vitamin B12) daily with two main meals for 8 weeks. The calcium supplement is made using calcium carbonate powder and the B12 supplement is made using cyanocobalamin powder at the School of Pharmacy, Shiraz University of Medical Sciences. Intervention 2: Control group: In the control group, individuals receive two capsules containing 500 mg of placebo (starch) with the same characteristics in terms of shape, smell, color, etc., along with two main meals every day for 8 weeks. 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 There is no more information available.
public Seyedeh parastoo Pasban
Shiraz university of medical science
Shiraz Iran (Islamic Republic of) 7134814336 +98 61 5287 1589 parastoo_pasban@yahoo.com Shiraz University of Medical Sciences scientific Afsaneh Ahmadi
Razi Blvd, School of Nutrition and food science
Shiraz Iran (Islamic Republic of) 14336 - 71348 0098 7137251001-8 ahmadi.afsane@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Individuals with metabolic syndrome according to ATP III criteria who tend to participate in research Age range of 18-65 years old. Not suffering from kidney, liver, chronic diseases, malignancies, and systemic diseases. Not supplementation of calcium, vitamin B12, chromium, magnesium, and vitamin D for the past 3 months before the study. 18 years 65 years Both pregnant and lactating women E88.81 Metabolic syndrome Treatment - Other Placebo Intervention group: In this group, individuals will receive 500 mg of calcium carbonate supplement and 500 mcg of cyanocobalamin (vitamin B12) daily with two main meals for 8 weeks. The calcium supplement is made using calcium carbonate powder and the B12 supplement is made using cyanocobalamin powder at the School of Pharmacy, Shiraz University of Medical Sciences. Control group: In the control group, individuals receive two capsules containing 500 mg of placebo (starch) with the same characteristics in terms of shape, smell, color, etc., along with two main meals every day for 8 weeks. Serum insulin. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Enzyme-linked immuno_sorbent assay (ELISA) kit. Blood glucose. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Calorimetric Laboratory. HOMA-IR index. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: (Glucose ×insulin)/405. Body Weight. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: scale. Body mass index. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: By calculating using the formula with using height and weight. Waist circumference. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: stadiometer. Systolic blood pressure. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Digital sphygmomanometer. Diastolic blood pressure. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: Digital sphygmomanometer. Total cholestrol. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: colorimetric method. Triglyceride. Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: colorimetric method. LDL (low-density lipoprotein). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: colorimetric method. HDL (high-density lipoprotein). Timepoint: At the beginning of the study (before the intervention) and the end of the study (8 weeks after the intervention). Method of measurement: colorimetric method. Shiraz University of Medical Sciences Approved 2023-08-06 Research Ethics Committees of Schools of Health and Nutrition-Shiraz University of Medical Sciences Razi Blvd, School of Health and Nutrition Shiraz Fars Iran (Islamic Republic of)