Investigating the Effects of Single Dose and Co-Supplementation of Vitamin D and Omega-3 on Anthropometric Factors, Lipid and Glycemic Profile, and the Status of Sex Hormone Binding Globulin in Women with Polycystic Ovary Syndrome
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General information
2018-04-28, 1397/02/08
2017-12-21, 1396/09/30
20182017-0412-2821 00:00:00
Due to some changes that we had to make while working in the project method.
With regards, the only changes that the research team requests to update the information and match it with the extracted article are the addition of the height factor and the correction of the study completion date. The rest of the information has already been confirmed.
Due to someWith regards, the only changes that we hadthe research team requests to make while working inupdate the project methodinformation and match it with the extracted article are the addition of the height factor and the correction of the study completion date. The rest of the information has already been confirmed.
به علت برخی تغییرات که مجبور بودیم در حین کار در متود پروژه داشته باشیم.
با سلام و احترام، تنها تغییراتی که تیم تحقیق جهت آپدیت اطلاعات و همسان سازی با مقاله استخراج شده تقاضای انجام دارند، اضافه شدن فاکتور قد و تصحیح تاریخ اتمام مطالعه نیز می باشد. مابقی اطلاعات قبلا تایید گردیده اند.
به علت برخی تغییراتبا سلام و احترام، تنها تغییراتی که مجبور بودیم در حین کار در متود پروژه داشته باشیمتیم تحقیق جهت آپدیت اطلاعات و همسان سازی با مقاله استخراج شده تقاضای انجام دارند، اضافه شدن فاکتور قد و تصحیح تاریخ اتمام مطالعه نیز می باشد. مابقی اطلاعات قبلا تایید گردیده اند.
Secondary outcomes
#1
empty
Height
Height
empty
قد
قد
empty
Beginning and end of the study (first week and eighth week)
Beginning and end of the study (first week and eighth week)
empty
ابتدا و انتهای مطالعه (هفته ی اول و هفته ی هشتم)
ابتدا و انتهای مطالعه (هفته ی اول و هفته ی هشتم)
empty
With minimum coverage and no shoes, using wall meter
With minimum coverage and no shoes, using wall meter
empty
با حداقل پوشش و بدون کفش با استفاده از متر دیواری
با حداقل پوشش و بدون کفش با استفاده از متر دیواری
Protocol summary
Study aim
The comparison of the effects of vitamin D-omega-3 fatty acids co-supplementation with vitamin D and omega-3 fatty acids alone on anthropometric, metabolic stress, hypertension and and serum androgen profile in women with poly cystic ovary syndrome
Design
This study was a randomized double-blind placebo-controlled Parallel 4 group of eight weeks clinical trial
Settings and conduct
At the beginning of the present study,all patients were asked to carry out their capsules in second (end of week 4) and third (end of Eighth week) to ensure full consumption . Follow patients to control them in terms of taking capsules, the possibility of severe side effects or symptoms of poisoning with supplements used and to prevent the loss of samples, each week to telephone and also through referring patients to Shahid Motahari Clinic in Shiraz at the end of the fourth and eighth weeks
Participants/Inclusion and exclusion criteria
Inclusion criteria
This syndrome is defined by the Rotterdam Diagnostic Criteria by Gynecologist
Excluding any drug or surgical treatment to treat clinical symptoms associated with polycystic ovary syndrome except ocp ; No history of any allergy, intolerance or harmful drug reaction to the studied supplements, Age range ..18-45 ; Ability to understand study objectives and provide written informed consent
Being within the BMI range of 18.5-45 ; Residence in Shiraz and willingness to participate in the study
Exclusion criteria
The incidence of severe side effects or symptoms of poisoning with supplements used during the study period;Initiate intake or any changes in the type or dosage;Getting pregnant during the study period;Non-adherence to the study protocol
Intervention groups
The four groups of each group are 20 (a) vitamin D and omega-3, B) vitamin D and pelacebo omega-, 3 C) Omega-3 and pelacebo vitaminD, d)pelacebo
Main outcome variables
metabolic indicators
General information
Reason for update
With regards, the only changes that the research team requests to update the information and match it with the extracted article are the addition of the height factor and the correction of the study completion date. The rest of the information has already been confirmed.
Acronym
IRCT registration information
IRCT registration number:IRCT20100223003408N7
Registration date:2020-02-23, 1398/12/04
Registration timing:retrospective
Last update:2022-09-19, 1401/06/28
Update count:2
Registration date
2020-02-23, 1398/12/04
Registrant information
Name
Maryam Ekramzadeh
Name of organization / entity
Shiraz University of Medical Sciences, Nutrition Department
Country
Iran (Islamic Republic of)
Phone
+98 917 317 3891
Email address
ekramzadeh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-05, 1396/01/16
Expected recruitment end date
2017-09-11, 1396/06/20
Actual recruitment start date
2017-04-30, 1396/02/10
Actual recruitment end date
2017-10-17, 1396/07/25
Trial completion date
2017-12-21, 1396/09/30
Scientific title
Investigating the Effects of Single Dose and Co-Supplementation of Vitamin D and Omega-3 on Anthropometric Factors, Lipid and Glycemic Profile, and the Status of Sex Hormone Binding Globulin in Women with Polycystic Ovary Syndrome
Public title
Investigating the Effects of Single Dose and Co-Supplementation of Vitamin D and Omega-3 in women with poly cystic ovary syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
This syndrome is defined by the Rotterdam Diagnostic Criteria by Gynecologist
Excluding any drug or surgical treatment to treat clinical symptoms associated with polycystic ovary syndrome except ocp
No history of any allergy, intolerance or harmful drug reaction to the studied supplements
Age range ..18-45
Being within the BMI range of 18.5-40
Ability to understand study objectives and provide written informed consent
Residence in Shiraz and willingness to participate in the study
Exclusion criteria:
Suffering from hormonal disorders including Edison's disease, Cushing's disease, hyperparathyroidism, hypo- or hyperthyroidism
Having history of chronic diseases including cancer, heart disease, diabetes, stroke, fibromyalgia, kidney, or liver defects
Having history of food and drug allergies
Starting drug or surgical therapy for clinical symptoms associated with PCOS except oral contraceptive pills (OCPs)
Smoking or any drug addiction
Pregnancy and lactation
Being on a special diet in the last year
Using any dietary supplement,
Having oral or injectable nutritional supplements containing vitamin D in the last 3 months
Consuming nutritional supplements containing fish oil or Omega-3 fatty acids in the last 3 months
Having fish in the diet more than 3 servings per week during last 3 months
History of severe side effects or symptoms of poisoning with the current study supplements
Lack of adherence to the study protocol
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
107
More than 1 sample in each individual
Number of samples in each individual:
2
The beginning and the end of the study
Actual sample size reached:
80
More than 1 sample in each individual
Actual sample size in each individual:
2
The beginning and the end of the study
Randomization (investigator's opinion)
Randomized
Randomization description
samples were categorized using a Permuted block randomization method (29) based on whether or not using OCP by using Random Allocation Software as 1: 1: 1: 1 and equally to one of the 4 groups
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinded groups in the study include participants and researchers.
After selecting the samples, none of the sampled people will know about randomization and the process of allocation to groups. The doctor is given a table of coded numbers in advance, and the patients are entered into the study in the order of the numbers in the table. Therefore, the present study is double-blind. Vitamin D, Omega-3 and placebo capsules have the same shape, color, and size and are delivered to the patient in the package.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
shiraz university of medical science
Street address
zand street
City
shiraz
Province
Fars
Postal code
7134814336
Approval date
2018-01-31, 1396/11/11
Ethics committee reference number
IR.SUMS.REC.1396.103
Health conditions studied
1
Description of health condition studied
polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
polycystic ovary syndrome
Primary outcomes
1
Description
TG
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
Autoanalyzer
2
Description
TC:total cholesterol
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
Autoanalyzer
3
Description
HDL-C:high-density lipoprotein cholesterol
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
Autoanalyzer
4
Description
LDL-C:Low-density lipoprotein cholesterol
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
Autoanalyzer
Secondary outcomes
1
Description
sex hormone binding globulin :SHBG
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
ELISA
2
Description
FBS: fasting blood sugar
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
Autoanalyzer
3
Description
Physical Activity
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
questionnaire
4
Description
Weight
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
Low-weight, no-shoe weight using Digital Balance Digital Balance
5
Description
BMI:body mass index
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
Formula
6
Description
WC: Waist circumference
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
Meter
7
Description
Homeostasis model assessment insulin resistance (HOMA-IR)
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
Formula
8
Description
serum Insulin
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
ELISA
9
Description
Height
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
With minimum coverage and no shoes, using wall meter
Intervention groups
1
Description
Vitamin D group: received one vitamin D capsule (Zahravi Pharmaceutical Company, Tehran, Iran) (50000 IU/weekly) + two placebo capsules (paraffin oil; daily).
Category
Treatment - Other
2
Description
Omega-3 (O3) group: received two O3 capsules (Zahravi Pharmaceutical Company, Tehran, Iran) daily (each one contained 360 mg eicosapentaenoic acid (EPA) and 240 mg docosahexaenoic acid (DHA) ) + one placebo capsule (paraffin oil; weekly).
Category
Treatment - Other
3
Description
Vitamin D + O3 group: received one vitamin D capsule (50000 IU/weekly) + two O3 capsules daily (each one contained 360 mg EPA and 240 mg DHA ).
Category
Treatment - Other
4
Description
Placebo group: received one placebo capsule (paraffin oil; weekly) + two placebo capsule (paraffin oil; daily).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Clinic in Shiraz
Full name of responsible person
Dr. Nasrin Asadi
Street address
Namazi Square Clinic of Shahid Motahari
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸-۷۱۴۷۳۷
Phone
+98 71 3612 1000
Fax
+98 71 3647 4673
Email
Motahari@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Hatam
Street address
Zand Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3725 1006
Email
Ekramzadeh@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Maryam Ekramzade
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Razi-Blvi
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1006
Email
M_Ekramzade@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Maryam Ekramzade
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Razi-Blv
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1006
Email
M_Ekramzade@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hadis Bahramian
Position
Unemployed
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Shirz-Blv
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1006
Email
Hadis.bahramian@gmail.com
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
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