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IRCT20200713048089N1 IRCT 2020-07-15 Shahid Beheshti University of Medical Sciences Vitamin D supplementation and insulin homeostasis among healthy overweight and obese adults. The Effect of the Vitamin D Supplementation in Obese and Non-Diabetic Individuals; a Double Blind Randomized Clinical Trial. 2020-07-22 anticipated 70 Complete https://irct.ir/trial/49587 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Simple randomization; Random unit: Individual; Randomization tool: Coin tossing Eligible participants are blindly divided, in a parallel manner (1:1), into two equal groups via simple randomization. For the randomization the groups are named as vitamin D and placebo groups. In order to randomize, no individual is superior to another. Then, the sequence of groups is drawn up by coin tossing. In this method, a random number will be assigned to each participant. Then by coin tossing each number (individual) will be assigned to study groups alternately, Blinding description: The participants are blind to the treatment (vitamin D or placebo) that they will take. Also, the investigators are blind to the type of treatment which any participant receives. But care providers which are responsible for health of individuals are not blind to the treatment and if any contraindication or problem occurs, they will take suitable actions. Furthermore, outcome assessors and data analyzers are blind to the type of treatments. N/A Diabetes mellitus، Vitamin D deficiency. Intervention 1: Intervention group: The participants in vitamin D group will receive a 50000 IU pearl of vitamin D per week for 8 weeks. The participants are recommended to not change their overall routine physical activity and diet within the study. The compliance for treatment, probable complications and medication side effects are regularly followed via telephone contacts. Intervention 2: Control group: Placebo group will receive a pearl of placebo instead of vitamin D per week for eight weeks. The placebo is similar to the study medication in shape, color, size and taste. The participants are recommended to not change their overall routine physical activity and diet within the study. The compliance for treatment, probable complications and medication side effects are regularly followed via telephone contacts. Yes - There is a plan to make this available What will be shared: All of the data and documents will be published via an article after the end of the study. It should be considered that all of the identity of participants will remain confidential among researchers and no personal information will revealed. When: After end of the study. About 3 months after sampling To whom: All of the researchers, scientists and students Conditions: All of the data should use for further investigations. All of the researchers, scientists and students can send their request. Where to obtain: sa.ebadi@sbmu.ac.ir How to obtain: After sending the identification documents the documents will send less than 2 weeks. Comments:
public Seyed Alireza Ebadi
No 12, 109 Street, Tehranpars
Tehran Iran (Islamic Republic of) 1651994687 +98 21 7797 6409 sa.ebadi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Seyed Alireza Ebadi
No 12, 109 Street, Tehranpars
Tehran Iran (Islamic Republic of) 1651994687 +98 21 7797 6409 sa.ebadi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 65 years Body Mass Index (BMI) ≥ 25 kg/m2 Serum level of vitamin D < 30 mg/dl 18 years 65 years Both Any history of diabetes mellitus, thyroid disorders, gastrointestinal disorders, chronic inflammatory diseases, malignancy, kidney stones, cardiovascular events Taking of drugs which have effects on calcium and phosphorus hemostasis including corticosteroids, thyroxine, warfarin, bisphosphonates, thiazides and vitamin D pregnant or lactating women are not allowed to participate in the study E08 Diabetes mellitus due to underlying condition Treatment - Drugs Placebo Intervention group: The participants in vitamin D group will receive a 50000 IU pearl of vitamin D per week for 8 weeks. The participants are recommended to not change their overall routine physical activity and diet within the study. The compliance for treatment, probable complications and medication side effects are regularly followed via telephone contacts. Control group: Placebo group will receive a pearl of placebo instead of vitamin D per week for eight weeks. The placebo is similar to the study medication in shape, color, size and taste. The participants are recommended to not change their overall routine physical activity and diet within the study. The compliance for treatment, probable complications and medication side effects are regularly followed via telephone contacts. Serum level of vitamin D. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Serum level of vitamin D will measure using HPLC method with Aglient device. ّFasting insulin. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Serum level of fasting insulin will measure using ELISA method with Monobind laboratory kit. Homeostasis Model Assessment 2 for insulin resistance. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: l of Homeostasis Model assessment will measure using HOMA2 calculator (www.dtu.ox.ac.uk/homacalculator). Homeostasis Model Assessment 2 for β-cell function. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: l of Homeostasis Model assessment will measure using HOMA2 calculator (www.dtu.ox.ac.uk/homacalculator). Homeostasis Model Assessment 2 for insulin sensitivity. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: l of Homeostasis Model assessment will measure using HOMA2 calculator (www.dtu.ox.ac.uk/homacalculator). Shahid Beheshti University of Medical Sciences Approved 2017-07-11 Ethics committee of Shahid Beheshti University of Medical Sciences 7th floor, Bldg No.2. Arabi Ave, Velenjak, Tehran Tehran Tehran Iran (Islamic Republic of)