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Effect of Menaquinone supplementation on insulin resistance, lipid profile, anthropometric measurments, endocrine markers and oxidative stress in patients with polycystic ovary syndrome who will be referred to health centers of Shiraz University of Medical Sciences, 1396.

Protocol summary

Summary
Objectives: The aim of current study is evaluation of the efficacy of 8-week oral supplementation of menaquinone on body mass index (BMI), waist circumference (WC), body composition, plasma level of fasting blood sugar (FBS), lipid profile, endocrine markers (including insulin, sex hormone binding globulin, dehydroepiandrosterone Sulfate, dihydrotestosterone) and malondialdehyde (MDA) in patients with polycystic ovary syndrome. Design: 84 patients participate in this study which is a double-blind and randomized placebo-control clinical trial. Setting and conduct: Patients in this study were randomly divided into two groups: 42 patiens in case group recieve 90 microgram menaquinone and 42 patients in control group recieve placebo. Patients will be supplemented for 8 weeks. Participants including major eligibility criteria: Inclusion criteria: Suffering from polycystic ovary syndrome based on Rotterdam criteria; age between 18 to 40 ; absecnce of pregnancy or lactation; absence of antidiabetic, antihypertensive, antihyperlipidemic, anticoagulant treatment; absence of using metformin 2 months before entering the study and during the intervention; acute or chronic inflammation; absence of any current diet or supplement treatment; absence of antidiabetic, antihypertensive, antihyperlipidemic treatment; absence of using drugs effective on bone metabolism; any disease or physiological changes that requires special treatment; nonsmoker, nonalcoholic. Exclusion criteria: Failure to follow the intervention designing (not consuming dedicated supplement to the total amount less than 90% predicted or more than 3 days). Inteventions: Taking 1 capsule containing menaquinone per day in case group and 1 capsule containing placebo daily in control group. Main outcome measures: Anthropometric indices, dietary intake, physical activity, hirsuitism score, acne score, biochemical parameters , and endocrine markers were measured at the baseline and after 8-week intervention. Data analysis: Data analysis will be carried out by using SPSS software version 16.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017092836204N2
Registration date: 2017-10-25, 1396/08/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-25, 1396/08/03
Registrant information
Name
Najmeh Hejazi
Name of organization / entity
Shiraz University of Medical Sciences, Faculty of Nutrition and Food Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1005
Email address
nhejazi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-09-27, 1396/07/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Menaquinone supplementation on insulin resistance, lipid profile, anthropometric measurments, endocrine markers and oxidative stress in patients with polycystic ovary syndrome who will be referred to health centers of Shiraz University of Medical Sciences, 1396.
Public title
Effect of Menaquinone supplementation on insulin resistance, lipid profile, anthropometric measurments, endocrine markers and oxidative stress in patients with polycystic ovary syndrome who will be referred to health centers of Shiraz University of Medical Sciences, 1396.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Suffering from polycystic ovary syndrome based on Rotterdam criteria; age between 18 to 40 ; absecnce of pregnancy or lactation; absence of antidiabetic, antihypertensive, antihyperlipidemic, anticoagulant treatment; absence of using metformin 2 months before entering the study and during the intervention; acute or chronic inflammation; absence of any current diet or supplement treatment; absence of antidiabetic, antihypertensive, antihyperlipidemic treatment; absence of using drugs effective on bone metabolism; any disease or physiological changes that requires special treatment; nonsmoker, nonalcoholic. Exclusion criteria: Unwillingness to continue; any disease or physiological changes that requires special treatment; failure to follow the intervention designing (not consuming dedicated supplement to the total amount less than 90% predicted or more than 3 days).
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
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

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2017-04-17, 1396/01/28
Ethics committee reference number
IR.SUMS.REC.1396.6

Health conditions studied

1

Description of health condition studied
polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
polycystic ovarian syndrome

Primary outcomes

1

Description
fasting blood sugar
Timepoint
Before and after intervention
Method of measurement
auto analyser

2

Description
Dehydroepiandrosterone Sulfate (DHEAS)
Timepoint
Before and after intervention
Method of measurement
ELISA kit

Secondary outcomes

1

Description
total testosterone
Timepoint
Before and after intervention
Method of measurement
ELISA kit

2

Description
Malondialdehyde (MDA)
Timepoint
Befor and after intervention
Method of measurement
Spectrophotometry

3

Description
dihydrotestosterone (DHT)
Timepoint
Before and after intervention
Method of measurement
ELISA kit

4

Description
Sex Hormone Binding Globulin (SHBG)
Timepoint
Before and after intervention
Method of measurement
ELISA kit

5

Description
lipid profile (TG, Cholesterol, HDL, LDL)
Timepoint
Before and after intervention
Method of measurement
auto analyser

6

Description
fasting insulin
Timepoint
Before and after intervention
Method of measurement
ELISA kit

Intervention groups

1

Description
Intervention group: 1 capsule containing 90 micrograms of menaquinone per day for 8 weeks
Category
Treatment - Drugs

2

Description
Control group: 1 placebo capsule containing avesil per day for 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghadir Mother and Child Hospital, Infertility Clinic
Full name of responsible person
Dr. Bahia Namavar Jahromi
Street address
At the entrance to Golshan town, Imam Reze blvd
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Office of Research and Technology, Seventh Floor, Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
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, Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences, Faculty of Nutrition and Food Sciences
Full name of responsible person
Firoozeh Tarkesh
Position
MSc student
Other areas of specialty/work
Street address
Department of Nutrition and Food Science, Fatholmobin alley, Razi blvd
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
firoozeh_tarkesh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences, Faculty of Nutrition and Food Sciences
Full name of responsible person
Najmeh Hejazi
Position
Ph.D. in Nutritional Sciences, Assistant Professor
Other areas of specialty/work
Street address
Department of Nutrition and Food Science, Fatholmobin alley, Razi blvd
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
Nhejazi@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences, Faculty of Nutrition and Food Sciences
Full name of responsible person
Firoozeh Tarkesh
Position
MSc student
Other areas of specialty/work
Street address
Department of Nutrition and Food Science, Fatholmobin alley, Razi blvd
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
firoozeh_tarkesh@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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