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

Effects of vitamin K2 (MK-7) oral supplementation on glycemic control and lipid profile in individuals with type 2 diabetes

A clinical trial with control, parallel group, double blinded, randomized

Eligible individuals are selected from diabetes clinics of Shahid Beheshti hospitals who are volunteer to participate in the study by using data collection form. َAllocation concealment is simple and individually. All the participants and the researchers were blinded to the treatment allocation. The research coordinator, the person who will not participate in the study, labeled these containers based on the cods of our randomized list.

Inclusion criteria: Patients with type 2 diabetes who have diabetes since 1 year ago and currently are treated only with oral glucose lowering medications. Based on laboratory results, their glycosylated hemoglobin should be between 6.5 and 10%. Exclusion criteria: Those who having allergy to vitamin K, pregnant and lactating women, and patients with cardiovascular, liver, and kidney diseases are not included in to the study. Insulin injection

The intervention group will receive 180-mcg vitamin K2 capsules as a form of MK-7, twice daily after breakfast and dinner for 12 weeks (3 months). The placebo group will receive placebo capsules twice a day after breakfast and dinner for 12 weeks (3 months). Placebo capsules were filled with Avicel with identical appearance to the vitamin K. The vitamin K2 and placebo capsules were made by Arian Salamat Sina Pharmaceutical Company.

Fasting plasma glucose, Fasting plasma insulin, Glycated hemoglobin A1C, Insulin resistance indexes, Serum triglyceride, Serum total cholesterol, High-density lipoproteinn, Low-density lipoprotein

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.

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.