History
# Registration date Revision Id
3 2022-09-17, 1401/06/26 240774
2 2022-07-03, 1401/04/12 233086
1 2020-02-23, 1398/12/04 122987
Changes made to previous revision
This is the first revision

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, blood pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100223003408N7
Registration date: 2020-02-23, 1398/12/04
Registration timing: retrospective

Last update: 2020-02-23, 1398/12/04
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
2017-12-16, 1396/09/25
Scientific title
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
Public title
The comparison of the effects of vitamin D-omega-3 fatty acids co-supplementation 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:
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
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: 80
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: 62
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
Before the beginning of an individual study other than the researcher who was unaware of the objectives of the study, without notifying the researcher, vitamin D capsules in cans labeled A and placebo capsule of vitamin D in cans labeled B and capsules of omega-3 fatty acids in cans with the label C and placebo capsules put omega-3 fatty acids in cans labeled D.On the other hand, the usage instructions for each of the cans (including the number of capsule to be received daily or weekly, and of course, how they are used) were placed inside each cans.Then, according to the design of the study, the subjects received one of the possible AC combinations (which can be specific to one of the vitaminD-omega-3 or placebo groups),AD, CB, Ador BD.
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
blood pressure
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
Digital arterial blood pressure monitor

2

Description
TG
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
Autoanalyzer

3

Description
TC:total cholesterol
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
Autoanalyzer

4

Description
HDL-C:high-density lipoprotein cholesterol
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
Autoanalyzer

5

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
MDA: Malondialdehyde
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
Spectrophotometry

3

Description
FSI: fasting serum insulin
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
ELISA

4

Description
FBS: fasting blood sugar
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
Autoanalyzer

5

Description
Physical Activity
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
questionnaire

6

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

7

Description
dietry recall 24 h
Timepoint
Completed for two days midweek and one day off on first, second and third visits through face-to-face interviews with each patient
Method of measurement
questionnaire

8

Description
BMI:body mass index
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
Formula

9

Description
WC: Waist circumference
Timepoint
Beginning and end of the study (first week and eighth week)
Method of measurement
Meter

Intervention groups

1

Description
Intervention group:2 omega-3 capsules(EPA:780 mg/d,mg/d DHA:420) daily and one vitamin D capsule weekly( 50000 IU/week) for 2 months All supplements and placebo were made by Zahravi Pharmaceutical Company of Iran and were similar in color and form. At the beginning of the study (first visit at the beginning of the first week) all patients were asked to visit the second (end of the fourth week) and third visits. (End of Week 8) Have the cans with their capsules to ensure full consumption (counting capsules and adherence assessment)It is noteworthy that In the first and second visits, only the supplement required for 4 weeks was given to each participant.
Category
Treatment - Other

2

Description
Intervention group: 2 omega-3 placebo capsules(Paraffin) daily and one vitamin D capsule weekly ( 50000 IU/week)for 2 months
Category
Treatment - Other

3

Description
Intervention group: 2 omega-3 capsules daily and one vitamin D placebo capsule weekly for 2 months
Category
Treatment - Other

4

Description
Control group: Vitamin D and Omega-3 placebo
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
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