Protocol summary
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Study aim
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The aim of this study is evaluation of the efficacy of 8-week supplementation with Menaquinone(MK-7) on deppression status, fasting glucose and serum vitamin K level in patients with polycystic ovary syndrome.
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Design
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This double-blinded, Randomised, placebo-controlled, parallel group clinical trial will be carried out on 84 patients suffering from polycystic ovary syndrome. In this study patients will be selected based on inclusion criteria and they will be followed for 8 weeks. Demographic information and depression questionnaires will be completed by each patient. Also, 5 cc of fasting blood (to determine the level of fasting serum glucose and serum vitamin K) will be collected. In the next stage, patients will be divided into two groups of Menaquinone-7 and placebo through block randomization. The final visit of patients is going to be at the end of the trial and 5 cc of fasting blood will bw collected for the second time and depression questionnaires will be completed for the second time.
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Settings and conduct
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Patient recruitment and assessments in this double-blinded study will be executed in Ghadir hospital. Vitamin K and placebo capsules will be packaged in the similar boxes by an individual other than the researcher, therefore both researchers and patients won't be aware of the contents of the boxes.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Polycystic ovary syndrome; Being in the age range of 18-40 years; The desire to participate in the study.
Non inclusion criteria: Suffering from any Acute or chronic inflammatory disease; Using any medication or supplements
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Intervention groups
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The case group (42 patients) will receive one capsule containing 90 micrograms of menaquinone daily and the control group (42 patients) will receive a placebo capsule daily for 8 weeks.
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Main outcome variables
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fasting blood sugar-depression status-serum vitamin K
General information
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Reason for update
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The time period of recruiting patients was mistakenly written in the first version.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170916036204N5
Registration date:
2018-06-06, 1397/03/16
Registration timing:
retrospective
Last update:
2020-11-14, 1399/08/24
Update count:
1
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Registration date
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2018-06-06, 1397/03/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2017-06-22, 1396/04/01
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Expected recruitment end date
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2017-09-27, 1396/07/05
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of Menaquinone(MK-7) supplementation on deppression status, fasting blood sugar and serum vitamin K level in patients with polycystic ovary syndrome
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Public title
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effect of Menaquinone(MK-7) supplementation on deppression status in patients with polycystic ovary syndrome
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Inclusion criteria: Suffering from polycystic ovary syndrome based on Rotterdam criteria;
Age between 18 to 40
Exclusion criteria:
Unwillingness to participate
Any disease or physiological changes that requires special treatment
Pregnancy or lactation
Using antidiabetic, antihypertensives, antihyperlipidemics or anticoagulant treatment
Using metformin 2 months before entering the study and during the intervention;
Acute or chronic inflammation
Being smoker or/and alcoholic.
Using drugs effective on bone metabolism
Any current diet or supplement treatment
Using oral contraceptives
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
84
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Individuals will be classified into placebo and target groups with block randomization and Random allocation methods.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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All participants in this study are unaware about their grouping because the package, label, and appearance of Menaquinone and placebo capsules are quite similar. Vitamin K and placebo capsules will be packaged by an individual other than the researcher in the same boxes, therefore researchers are not aware of the contents of the boxes too.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-04-29, 1397/02/09
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Ethics committee reference number
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IR.SUMS.REC.1397.102
Health conditions studied
1
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Description of health condition studied
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Polycystic ovary syndrome
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ICD-10 code
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E28.2
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ICD-10 code description
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Polycystic ovarian syndrome
Primary outcomes
1
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Description
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Depression score in BECK questionnaire
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Timepoint
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Before and after the intervention
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Method of measurement
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BECK depression questionnaire
Secondary outcomes
1
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Description
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Serum vitamin K level
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Timepoint
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Before and after the intervention
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Method of measurement
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ELISA kit
2
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Description
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Fasting Blood Sugar
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Timepoint
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Before and after intervention
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Method of measurement
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auto analyser
Intervention groups
1
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Description
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Intervention group: A capsule containing 90 μg of menaquinone daily for 8 weeks
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Category
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Treatment - Drugs
2
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Description
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control group: A capsule containing avesil daily for 8 weeks
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable