This double blind randomized clinical trial study was designed to investigate the effects of vitamin k1 supplementation on sensitivity and insulin resistance via osteocalcin in prediabetic patients. A total of 84 patients aged 22 to 45 years and 100 ≤FBS≤126, or 140 ≤2hpp≤200mg/dL upon 75 g oral glucose tolerance test (75 g OGTT) who did not receive any medication are selected and randomly allocated into two equal groups of phylloquinone or placebo. The treatment group will receive one 1000 micrograms vitamin K1 as soft gel daily and the placebo group will receive similar soft gel daily as placebo for 4 weeks. Diet and physical activities will be held constant throughout the study. After obtaining the written informed consent, subjects will be assessed regarding dietary intake, anthropometric, clinical and medical history, and biochemical measurements of Carboxylated Osteocalcin(cOCN), Decarboxylated osteocalcin(ucOCN), Total osteocalcin, Leptin, Adiponectin and Glycosylated Haemoglobin(HbA1c )at the beginning and the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013120915724N1
Registration date:2014-01-08, 1392/10/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-08, 1392/10/18
Registrant information
Name
Hamid Rasekhi
Name of organization / entity
Ahvaz jundishapur university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 4445 1633
Email address
rasekhi.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Ahvaz jundishapur University of Medical Science
Expected recruitment start date
2013-04-09, 1392/01/20
Expected recruitment end date
2013-11-21, 1392/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin k1 supplementation on sensitivity and insulin resistance via osteocalcin in predaibetes patients:A Randomized clinical trial
Public title
The effect of vitamin k1 in diabetic patient treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study and sign the Written informed consent; Age between 22 to 45 years old; BMI=25-29.9 kg/m2; 100 ≤FBS≤126 or 140 ≤2hpp≤200 mg/dL
Exclusion criteria: Heart, Kidney, liver and Rheumatoid diseases; Osteoporosis; Hyperthyroidism and Thyroid dysfunction; Pregnancy; Lactation; Menopause; Intake of insulin and glucose and lipid-lowering Agents; Warfarin; Corticosteroids; drugs to treat osteoporosis; Vitamin and Mineral supplements during past 6 months.
Age
From 22 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur university of medical science, Ahvaz Jundishapur university of
Street address
Vice Chancellor For Research Of Ahvaz Jundishapur University Of Medical Science, Ahvaz, Iran
City
Ahvaz
Postal code
Approval date
2012-11-10, 1391/08/20
Ethics committee reference number
Eth-613
Health conditions studied
1
Description of health condition studied
prediabetes
ICD-10 code
R73.0
ICD-10 code description
Abnormal glucose tolerance test
Primary outcomes
1
Description
Serum carboxylated osteocalcin
Timepoint
Baseline and after 4 weeks
Method of measurement
ELISA assay
2
Description
serum carboxylated osteocalcin
Timepoint
Baseline and after 4 weeks
Method of measurement
ELISA assay
3
Description
serum total osteocalcin
Timepoint
Baseline and after 4 weeks
Method of measurement
ELISA assay
4
Description
serum Hb A1C
Timepoint
Baseline and after 4 weeks
Method of measurement
HPLC assay
5
Description
total energy and nutrient intaake
Timepoint
Baseline, middle and 4th weeks
Method of measurement
24 hour recall
Secondary outcomes
1
Description
fasting and 2 hour serum insulin
Timepoint
Baseline and after 4 weeks
Method of measurement
ELISA assay
2
Description
fasting and 2 hour serum glucose
Timepoint
Baseline and after 4 weeks
Method of measurement
calorimetric assay
3
Description
HOMA-IR
Timepoint
Baseline and after 4 weeks
Method of measurement
formula
4
Description
HOMA-%B
Timepoint
Baseline and after 4 weeks
Method of measurement
formula
5
Description
ISI
Timepoint
Baseline and after 4 weeks
Method of measurement
formula
6
Description
serum adiponectin
Timepoint
Baseline and after 4 weeks
Method of measurement
ELISA assay
7
Description
serum leptin
Timepoint
Baseline and after 4 weeks
Method of measurement
ELISA assay
8
Description
BMI
Timepoint
Baseline and after 4 weeks
Method of measurement
formula
9
Description
waist to hip ratio
Timepoint
Baseline and after 4 weeks
Method of measurement
formula
10
Description
bady fat
Timepoint
Baseline and after 4 weeks
Method of measurement
OMRON
Intervention groups
1
Description
Daily consumption of one 1000 micro grams soft gel vitamin k1 for 4 weeks in intervention group.
Category
Prevention
2
Description
Daily consumption of one softgel placebo for 4 weeks in the control group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Nutrition Research Center and Metabolic Disease
Full name of responsible person
Dr.Majid Karandish
Street address
Nutrition Research Center and Metabolic Disease, Vice Chancellor For Research Of Ahvaz Jundishapur University Of Medical Science, Ahvaz Jundishapur University Of Medical Science, Ahvaz, Iran
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research Of Ahvaz Jundishapur University Of Medical Science, Ahvaz Jundishapur
Full name of responsible person
Mostafa Feghhi
Street address
Vice Chancellor For Research Of Ahvaz Jundishapur University Of Medical Science, Ahvaz Jundishapur University Of Medical Science, Ahvaz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For Research Of Ahvaz Jundishapur University Of Medical Science, Ahvaz Jundishapur
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Hamid Rasekhi
Position
Ph.D Student
Other areas of specialty/work
Street address
Department of Nutrition, School of ParaMedicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1373 8253
Fax
Email
Rasekhi.h@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur university of medical science
Full name of responsible person
Majid Karandish
Position
AssociatePprofessor
Other areas of specialty/work
Street address
Department of Nutrition, School of ParaMedicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1373 8253
Fax
Email
Karandish-m@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Mcience
Full name of responsible person
Hamid Rasekhi
Position
Ph.D Student
Other areas of specialty/work
Street address
Department of Nutrition, School of ParaMedicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1373 8253
Fax
Email
Rasekhi.h@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)