Protocol summary

Study aim
Effects of vitamin K2 (MK-7) oral supplementation on glycemic control and lipid profile in individuals with type 2 diabetes
Design
A clinical trial with control, parallel group, double blinded, randomized
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Fasting plasma glucose, Fasting plasma insulin, Glycated hemoglobin A1C, Insulin resistance indexes, Serum triglyceride, Serum total cholesterol, High-density lipoproteinn, Low-density lipoprotein

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190824044592N1
Registration date: 2019-12-22, 1398/10/01
Registration timing: registered_while_recruiting

Last update: 2019-12-22, 1398/10/01
Update count: 0
Registration date
2019-12-22, 1398/10/01
Registrant information
Name
fatemeh rahimi sakak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2500
Email address
fatemeh.rahimisakak@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-26, 1398/07/04
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effect of vitamin K2 ( MK-7 ) in treatment of diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Insulin injection Have chronic diseases such as heart, liver, kidney, cancer disease Having allergy to vitamin K Pregnancy or lactation
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Reseearch Institute for Endocrine Sciencs of Shahid Beheshti University of Medic
Street address
No. 24, Aarabi Street, Yaman Street, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717413
Approval date
2019-03-18, 1397/12/27
Ethics committee reference number
IR.SBMU.ENDOCRINE.REC.1398.011

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
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

2

Description
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

3

Description
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

4

Description
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

Secondary outcomes

1

Description
Serum Triglycerides
Timepoint
At the beginning and exactly at the end of intervention ( 90 days later )
Method of measurement
Enzymatic colorimetric method

2

Description
Serum cholesterol
Timepoint
At the beginning and exactly at the end of intervention ( 90 days later )
Method of measurement
Enzymatic colorimetric method

3

Description
High-density lipoprotein
Timepoint
At the beginning and exactly at the end of intervention ( 90 days later )
Method of measurement
Enzymatic colorimetric method

4

Description
Low-density lipoprotein
Timepoint
At the beginning and exactly at the end of intervention ( 90 days later )
Method of measurement
Enzymatic colorimetric method

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Fatemeh Rahimi Sakak
Street address
Aarabi st, Yaman st, Velenjak, Chamran highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2500
Email
fatemeh.rahimisakak@sbmu.ac.ir

2

Recruitment center
Name of recruitment center
Tajrish Shohada Hospital
Full name of responsible person
Fatemeh Rahimi Sakak
Street address
Shohadae Tajrish Hospital, Tajrish Sq, Tehran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr_shohada@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fereidoun Azizi
Street address
No. 24, Shahid Arabi StIran, Yemen Blvd, Chamran Exp, Tehran,
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2500
Email
azizi@erc.ac.ir
Web page address
https://www.endocrine.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Moslehi
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 24, Shahid Arabi St, Yemen Blvd, Chamran Exp, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2500
Email
moslehinazanin@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parvin Mirmiran
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 46, Arghavan-e-gharbi St., Farahzadi Blvd., , Tehran, IranShahrak-e-qods
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7484
Email
mirmiran@endocrine.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Rahimi sakak
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 24, Shahid Arabi St, Yemen Blvd, Chamran Exp, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2500
Fax
Email
fatemeh.rahimisakak@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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