Effect of the therapeutic effect of chromium supplementation with doses of 400 and 600 micrograms on body mass index, insulin sensitivity and depression, anxiety and stress in polycystic ovary syndrome
Determination of the therapeutic effect of chromium supplementation with doses of 400 and 600 micrograms on body mass index, insulin sensitivity and depression, anxiety and stress in polycystic ovary syndrome
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 120 patients. Random allocation was used for randomization.
Settings and conduct
This study will be performed in the gynecology clinic of Shahrekord University of Medical Sciences on women with polycystic ovary syndrome who are eligible for the study. Patients who have consciously signed a consent form to participate in the project will be randomly (by block method) into three groups. Intervention group 1: Chromium supplement 400 micrograms daily orally for two months. Intervention group 2: Chromium supplement 600 micrograms per day orally for two months, intervention group 3: oral placebo tablets once daily for two months. participants and statistical expert are unaware of the type of drug used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with PCO
Exclusion criteria: take chromium picolinate supplement regularlyHydroxy; progesterone above 2
Intervention groups
Intervention group 1: Chromium supplement 400 micrograms daily orally for two months
Intervention group 2: Chromium supplement 600 micrograms one orally daily for two months
Intervention group 3: Oral placebo tablets once daily for two months
Effect of the therapeutic effect of chromium supplementation with doses of 400 and 600 micrograms on body mass index, insulin sensitivity and depression, anxiety and stress in polycystic ovary syndrome
Public title
Effect of the therapeutic effect of chromium supplementation with doses of 400 and 600 micrograms on body mass index
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction of patients aged 16 to 40 years
Polycystic Ovary Syndrome
Exclusion criteria:
Take chromium picolinate supplement regularlyHydroxy
Progesterone above 2
Age
From 16 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher will use a table of random numbers to select the sample. It randomly starts from a point in the table in the direction of a row or column. The selection of the point can be done by closing the eyes and placing a finger or the tip of a pen on the table. The movement does not differ in the direction of the row or column, and this is up to the researcher. But according to the type of code digits (one digit, two digits, three digits, etc.) he must select the same number of digits in the row or column direction. It then controls the route numbers. He will inevitably encounter two types of numbers, one of which is smaller than the number of the population of the study and the other of which is larger than the number of the population. He should only consider and select smaller numbers. The selected number is in fact the individual code of the community that is selected as a sample. This should be continued until a small number can be selected based on the number of sample people. After completing the sample size, the sampling work is completed.For this study, 80 sealed envelopes will be numbered 1-120 according to the randomization list. Group allocation will be kept separate until the study is completed. with 40 envelopes allocated to each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind ,after completing the study and collecting the results, the relevant codes will be provided to each patient team and the method of performing the double-blind nature of the study was such that neither the patient nor the researcher were aware of patient allocation. They were similarly packaged to avoid identification
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Vice Chancellor of Research and Technology, Shahrekord University of Medical Sciences,Kashani Blvd, Shahrekord,Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2021-04-20, 1400/01/31
Ethics committee reference number
IR.SKUMS.REC.1400.039
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Body mass index
Timepoint
Two months after the start of the intervention
Method of measurement
Questionaire
2
Description
Insulin sensitivity
Timepoint
Two months after the start of the intervention
Method of measurement
Questionaire
3
Description
Depression
Timepoint
Two months after the start of the intervention
Method of measurement
Questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Chromium supplement 400 micrograms of CENTURY company daily orally for two months
Category
Treatment - Drugs
2
Description
Intervention group 2: Chromium supplement 600 micrograms daily of CENTURY company orally for two months
Category
Treatment - Drugs
3
Description
Control group: Oral placebo tablets once daily for two months of Darupakhsh Company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital
Full name of responsible person
Belgheyse Mohammadi
Street address
Hajar Hospital of Shahrekord University of Medical Sciences, Parastar street, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3222 0016
Email
mohammadi.b@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghi
Street address
Vice Chancellor of Research and Technology, Shahrekord University of Medical Sciences,Kashani Blvd, Shahrekord,Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3224 2414
Email
sadeghi@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Belghese Mohammadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar Hospital of Shahrekord University of Medical Sciences, Parastar Avenue, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3222 0016
Email
mohammadi.b@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Belghese Mohammadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar Hospital of Shahrekord University of Medical Sciences, Parastar Avenue, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
009891332220016
Email
mohammadi.b@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Belghese Mohammadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hajar Hospital of Shahrekord University of Medical Sciences, Parastar Avenue, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
009832220016
Email
mohammadi.b@skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available