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IRCT20190824044592N1 IRCT 2019-12-22 Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences Effect of vitamin K2 ( MK-7 ) in treatment of diabetes Effects of vitamin K2 (MK-7) oral supplementation on glycemic control and lipid profile in individuals with type 2 diabetes: A double-blind randomized clinical tial 2019-09-26 anticipated 68 Complete https://irct.ir/trial/41728 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the intervention and placebo groups were received code A or code B by the person who did not participate in the research (Project executives and patients do not know which group is A and which group is B). Then this person created quadratic blocks and in each block half of the blocks were group A and the other half were group B. She wrote 6 possible states of blocks on 6 pieces of paper (AABB-ABAB-ABBA-BBAA-BABA-BAAB) and then she put these six pieces in a container and she randomly selected one of these six papers from the container 17 times and note the composition written on it. Since our sample size was 68 people, she totally selected the blocks 17 times. Finally, an arrangement was made that during the intervention, it will be clear which group A or B belongs to each patient, Blinding description: All the participants and the researchers were blinded to the treatment allocation. Sixty vitamin K capsules or Sixty placebo capsules were placed into 204 identical containers. 3 containers will be given to each patient during the intervention. The research coordinator, the person who will not participate in the study, labeled these containers based on the cods of our randomized list. 3 Diabetes. Intervention 1: Intervention group: After 12 h fasting, blood samples were collected at the beginning and end of week 12. Patients of this group will intake 180 mcg vitamin k2 (MK-7) twice daily after breakfast and dinner for 12 weeks. Phone calls were made to remind the participants about supplement consumption at the end of each week. Follow-up visits were carried out every 4 weeks while the supplements were delivered again. For dietary intake assessment, all of the participants were asked to record their dietary intakes for 3 days (one weekend day and two workdays) at baseline and end of the study. Vitamin K2 capsules were produced by Ariansalamat Sina pharmaceutical company, Iran. Intervention 2: Control group: After 12 h fasting, blood samples were collected at the beginning and end of week 12. Patients of this group will intake placebo of vitamin K2 capsules twice daily after breakfast and dinner for 12 weeks. Phone calls were made to remind the participants about supplement consumption at the end of each week. Follow-up visits were carried out every 4 weeks while the supplements were delivered again. For dietary intake assessment, all of the participants were asked to record their dietary intakes for 3 days (one weekend day and two workdays) at baseline and end of the study. Placebo of vitamin K2 capsules were produced by Ariansalamat Sina pharmaceutical company, Iran. Placebo capsules were filled with Avicel with identical appearance to the vitamin K. 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.
public Nazanin Moslehi
No. 24, Shahid Arabi St, Yemen Blvd, Chamran Exp, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717413 +98 21 2243 2500 moslehinazanin@sbmu.ac.ir Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences scientific Parvin Mirmiran
No. 46, Arghavan-e-gharbi St., Farahzadi Blvd., , Tehran, IranShahrak-e-qods
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7484 mirmiran@endocrine.ac.ir Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients who have diabetes since 1 year ago Glycated hemoglobin between 6.5 and 10 % Not intake of Warfarin, Phenytoin, Phenobarbital, Dicoumarol, Phenprocoumon drugs Patients treating with oral lowering blood glucose medications 30 years 70 years Both Insulin injection Have chronic diseases such as heart, liver, kidney, cancer disease Having allergy to vitamin K Pregnancy or lactation E11 Type 2 diabetes mellitus Treatment - Drugs Treatment - Drugs Intervention group: After 12 h fasting, blood samples were collected at the beginning and end of week 12. Patients of this group will intake 180 mcg vitamin k2 (MK-7) twice daily after breakfast and dinner for 12 weeks. Phone calls were made to remind the participants about supplement consumption at the end of each week. Follow-up visits were carried out every 4 weeks while the supplements were delivered again. For dietary intake assessment, all of the participants were asked to record their dietary intakes for 3 days (one weekend day and two workdays) at baseline and end of the study. Vitamin K2 capsules were produced by Ariansalamat Sina pharmaceutical company, Iran. Control group: After 12 h fasting, blood samples were collected at the beginning and end of week 12. Patients of this group will intake placebo of vitamin K2 capsules twice daily after breakfast and dinner for 12 weeks. Phone calls were made to remind the participants about supplement consumption at the end of each week. Follow-up visits were carried out every 4 weeks while the supplements were delivered again. For dietary intake assessment, all of the participants were asked to record their dietary intakes for 3 days (one weekend day and two workdays) at baseline and end of the study. Placebo of vitamin K2 capsules were produced by Ariansalamat Sina pharmaceutical company, Iran. Placebo capsules were filled with Avicel with identical appearance to the vitamin K Glycated hemoglobin A1c. Timepoint: Glycated hemoglobin A1c will be measured at the beginning of the study and after 90 days of starting supplementation. Method of measurement: Enzymatic colorimetric method. Fasting Plasma Insulin. Timepoint: Fasting Plasma Insulin will be measured at the beginning of the study (before the intervention) and after 90 days of starting supplementation . Method of measurement: Enzyme-linked immunosorbent assay. Fasting Plasma Glucose. Timepoint: Fasting Plasma Glucose will be measured at the beginning of the study (before the intervention) and after 90 days of starting supplementation. Method of measurement: Enzymatic colorimetric method. Insulin resistance indexes. Timepoint: Insulin resistance indexes will be calculated at the beginning of the study (before the intervention) and after 90 days of starting supplementation . Method of measurement: Calculation. Serum Triglycerides. Timepoint: At the beginning and exactly at the end of intervention ( 90 days later ). Method of measurement: Enzymatic colorimetric method. Serum cholesterol. Timepoint: At the beginning and exactly at the end of intervention ( 90 days later ). Method of measurement: Enzymatic colorimetric method. High-density lipoprotein. Timepoint: At the beginning and exactly at the end of intervention ( 90 days later ). Method of measurement: Enzymatic colorimetric method. Low-density lipoprotein. Timepoint: At the beginning and exactly at the end of intervention ( 90 days later ). Method of measurement: Enzymatic colorimetric method. Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences Approved 2019-03-18 Ethics Committee of Reseearch Institute for Endocrine Sciencs of Shahid Beheshti University of Medic No. 24, Aarabi Street, Yaman Street, Velenjak, Tehran Tehran Tehran Iran (Islamic Republic of)