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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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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
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  • Protocol summary

    metabolic indicators, blood pressure
    metabolic indicators
    شاخص های متابولیک و فشارخون
    شاخص های متابولیک

  • General information

    80
    107
    62
    80
    2017-12-16, 1396/09/25
    2018-04-28, 1397/02/08
    empty
    Due to some changes that we had to make while working in the project method.
    empty
    به علت برخی تغییرات که مجبور بودیم در حین کار در متود پروژه داشته باشیم.
    The comparison of the effects of vitamin D-omega-3 fatty acids co-supplementation in women with poly cystic ovary syndrome
    Investigating the Effects of Single Dose and Co-Supplementation of Vitamin D and Omega-3 in women with poly cystic ovary syndrome
    مقایسه اثر مکمل یاری توأم ویتامین D و اسیدهای چرب امگا-3 در زنان مبتلا به سندرم تخمدان پلی کیستیک
    بررسی اثرات مکملیاری تک دوز و توأم ویتامین D و امگا 3 در زنان مبتلا به سندرم تخمدان پلی کیستیک
    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
    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
    مقایسه اثر مکمل یاری توأم ویتامین D و اسیدهای چرب امگا-3 با ویتامین D و اسید چرب امگا-3 به تنهایی بر شاخص های آنتروپومتریک، متابولیک, فشارخون و پروفایل آندروژنی سرم در زنان مبتلا به سندرم تخمدان پلی کیستیک
    بررسی اثرات مکملیاری تک دوز و توأم ویتامین D و امگا 3 بر عوامل تن سنجی، نمایه لیپید و گلیسمی و وضعیت گلوبولین متصل به هورمون جنسی در زنان مبتلا به سندرم تخمدان پلی کیستیک
    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
    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
    بروز عوارض جانبی شدید یا علایم مسمومیت با مکمل های مورد استفاده در طی مدت مطالعه
    اغاز مصرف یا هر گونه تغییر در نوع یا دوز مصرفیocp
    باردار شدن در طی مدت مطالعه
    عدم پایبندی به پروتکل مطالعه
    مبتلا به اختلالات هورمونی از جمله بیماری ادیسون، بیماری کوشینگ، پرکاری پاراتیروئید، کم کاری یا پرکاری تیروئید
    داشتن سابقه بیماری های مزمن از جمله سرطان، بیماری قلبی، دیابت، سکته مغزی، فیبرومیالژیا، نقص کلیه یا کبد
    داشتن سابقه حساسیت غذایی و دارویی
    شروع درمان دارویی یا جراحی برای علائم بالینی مرتبط با PCOS به جز قرص های ضد بارداری خوراکی (OCPs)
    سیگار کشیدن یا هر نوع اعتیاد به مواد مخدر
    بارداری و شیردهی
    داشتن رژیم غذایی خاص در یک سال گذشته
    استفاده از هر نوع مکمل غذایی
    مصرف مکمل های خوراکی یا تزریقی حاوی ویتامین D در 3 ماه گذشته
    مصرف مکمل های غذایی حاوی روغن ماهی یا اسیدهای چرب امگا 3 در 3 ماه گذشته
    داشتن ماهی در رژیم غذایی بیش از 3 وعده در هفته در طول 3 ماه گذشته
    سابقه عوارض جانبی شدید یا علائم مسمومیت با مکمل های مطالعه حاضر
    عدم رعایت پروتکل مطالعه حاضر
    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.
    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.
    پیش از آﻏاز مطالعه فردی ﻏیر از پژوهشگر که از اهداف مطالعه بی اطلاع بود، بدون مطلع ساختن پژوهشگر ,کپسول های ویتامین D را در قوطی هایی با برچسب A و کپسول های دارونما ویتامین D را در قوطی هایی با برچسب B و کپسول های اسیدهای چرب امگا-3 را در قوطی هایی با برچسب C و کپسول های دارونما اسیدهای چرب امگا-3 را در قوطی هایی با برچسب D قرار داد.از طرفی، دستورالعمل مصرف محتوای هر یک از قوطی ها (شامل تعداد کپسولی که باید روزانه یا هفتگی دریافت شود و البته نحوه مصرف آنها) توسط این فرد در داخل هر قوطی قرار داده می شد. آنگاه، مطابق با طراحی مطالعه،افراد مورد بررسی یکی از ترکیب های قوطی احتمالی AC(که می تواند مختص یکی از گروه های ویتامینD- امگا-3 یا دارونما باشد) ، CB، ADو یا BD را دریافت می کردند
    گروه‌های کورشده در مطالعه شامل شرکت کننده و محقق می باشند. پس از انتخاب نمونه ها، هیچکدام از افراد نمونه در مورد تصادفی سازی و فرایند تخصیص به گروه ها اطلاعی نخواهند داشت. به پزشک جدول اعداد کدبندی شده ازقبل داده شده و بیماران را به ترتیب شماره های جدول وارد مطالعه می نمایند. لذا مطالعه حاضر دوسو کور می باشد. کپسول های ویتامین د، امگا ۳ و پلاسبو ازنظر شکل، رنگ و اندازه یکسان بوده و در بسته بندی تحویل بیمار می گردند.

  • Primary outcomes

    #1
    blood pressure
    TG
    فشارخون
    تری گلیسرید
    Digital arterial blood pressure monitor
    Autoanalyzer
    پایشگر دیجیتال فشار خون شریانی
    اتوانالایزر
    #2
    TG
    TC:total cholesterol
    تری گلیسرید
    کلسترول تام
    #3
    TC:total cholesterol
    HDL-C:high-density lipoprotein cholesterol
    کلسترول تام
    کلسترول لیپوپروتئین با چگالی بالا
    #4
    HDL-C:high-density lipoprotein cholesterol
    LDL-C:Low-density lipoprotein cholesterol
    کلسترول لیپوپروتئین با چگالی بالا
    کلسترول لیپوپروتئین با چگالی پایین
    #5
    LDL-C:Low-density lipoprotein cholesterol
    empty
    کلسترول لیپوپروتئین با چگالی پایین
    empty
    Beginning and end of the study (first week and eighth week)
    empty
    ابتدا و انتهای مطالعه(هفته ی اول و هفته ی هشتم)
    empty
    Autoanalyzer
    empty
    اتوانالایزر
    empty

  • Secondary outcomes

    #1
    MDA: Malondialdehyde
    FBS: fasting blood sugar
    مالون دی الدهید
    گلوکز ناشتا
    Spectrophotometry
    Autoanalyzer
    اسپکتروفوتومتری دستی
    اتوآنالایزر
    #2
    FSI: fasting serum insulin
    Physical Activity
    انسولین ناشتا
    فعالیت فیزیکی
    ELISA
    questionnaire
    الایزا
    پرسشنامه
    #3
    FBS: fasting blood sugar
    Weight
    گلوکز ناشتا
    وزن
    Autoanalyzer
    Low-weight, no-shoe weight using Digital Balance Digital Balance
    اتوآنالایزر
    وزن با حداقل پوشش و بدون کفش با استفاده از ترازوی دیجیتالی
    #4
    Physical Activity
    BMI:body mass index
    فعالیت فیزیکی
    نمایه ی توده بدنی
    questionnaire
    Formula
    پرسشنامه
    فرمول
    #5
    Weight
    WC: Waist circumference
    وزن
    دور کمر
    Low-weight, no-shoe weight using Digital Balance Digital Balance
    Meter
    وزن با حداقل پوشش و بدون کفش با استفاده از ترازوی دیجیتالی
    متر
    #6
    dietry recall 24 h
    Homeostasis model assessment insulin resistance (HOMA-IR)
    یادامد 24 ساعته
    ارزیابی مدل هموستاز مقاومت به انسولین (HOMA-IR)
    Completed for two days midweek and one day off on first, second and third visits through face-to-face interviews with each patient
    Beginning and end of the study (first week and eighth week)
    برای دو روز در میان هفته و یک روز تعطیل در ویزیت های اول ,دوم و سوم ازطریق مصاحبه حضوری برای هر یک از بیماران تکمیل شد
    ابتدا و انتهای مطالعه(هفته ی اول و هفته ی هشتم)
    questionnaire
    Formula
    پرسشنامه
    فرمول
    #7
    BMI:body mass index
    serum Insulin
    نمایه ی توده بدنی
    انسولین سرمی
    Formula
    ELISA
    فرمول
    الیزا
    #8
    WC: Waist circumference
    empty
    دور کمر
    empty
    Beginning and end of the study (first week and eighth week)
    empty
    ابتدا و انتهای مطالعه(هفته ی اول و هفته ی هشتم)
    empty
    Meter
    empty
    متر
    empty

  • Intervention groups

    #1
    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.
    Vitamin D group: received one vitamin D capsule (Zahravi Pharmaceutical Company, Tehran, Iran) (50000 IU/weekly) + two placebo capsules (paraffin oil; daily).
    گروه مداخله:روزانه 2 عدد کپسول امگا- 3 (EPA:780 mg/d و mg/d DHA:420)و هفتگی یک عدد کپسول ویتامین D ( 50000 IU/week) به مدت 2 ماه تمامی مکمل ها و دارونما ساخت شرکت داروسازی زهراوی ایران بوده و از لحاظ رنگ و شکل مشابه یکدیگر می باشند,در آﻏاز مطالعه حاضر (ویزیت اول درآﻏاز هفته اول) از تمامی بیماران خواسته شد تا در ویزیت های دوم (پایان هفته چهارم) و سوم (پایان هفته هشتم) قوطی کپسول های خود را برای اطمینان از مصرف کامل (شمارش کپسول ها و ارزیابی میزان پایبندی) با خود همراه داشته باشند شایان ذکر است که در ویزیت های اول و دوم،تنها مقدار مکمل مورد نیاز جهت مصرف 4 هفته ای به هر یک از شرکت کنندگان تحویل داده شد
    گروه ویتامین D: یک عدد کپسول ویتامین D (شرکت داروسازی زهروی، تهران، ایران) (50000 واحد بین المللی در هفته) + دو عدد کپسول دارونما (روغن پارافین، روزانه).
    #2
    Intervention group: 2 omega-3 placebo capsules(Paraffin) daily and one vitamin D capsule weekly ( 50000 IU/week)for 2 months
    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).
    گروه مداخله: روزانه 2 عدد کپسول دارونمای امگا-3( پارافین) و هفتگی یک عدد کپسول ویتامینD ( 50000 IU/week) به مدت 2 ماه
    گروه امگا 3 (O3): روزانه دو کپسول O3 (شرکت داروسازی زهروی، تهران، ایران) (هر کدام حاوی 360 میلی گرم ایکوزاپنتانوئیک اسید (EPA) و 240 میلی گرم دوکوزاهگزانوئیک اسید (DHA)) + یک کپسول دارونما (روغن پارافین، هفتگی) دریافت کردند.
    #3
    Intervention group: 2 omega-3 capsules daily and one vitamin D placebo capsule weekly for 2 months
    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 ).
    گروه مداخله: روزانه 2 عدد کپسول امگا-3 و هفتگی یک عدد کپسول دارونمای ویتامین D به مدت 2 ماه
    گروه ویتامین D + O3: یک کپسول ویتامین D (50000 واحد بین المللی در هفته) + دو کپسول O3 روزانه (هر کدام حاوی 360 میلی گرم EPA و 240 میلی گرم DHA) دریافت کردند.
    #4
    Control group: Vitamin D and Omega-3 placebo
    Placebo group: received one placebo capsule (paraffin oil; weekly) + two placebo capsule (paraffin oil; daily).
    گروه کنترل: دارونمای ویتامین D و امگا3
    گروه دارونما: یک کپسول دارونما (روغن پارافین؛ هفتگی) + دو کپسول دارونما (روغن پارافین؛ روزانه) دریافت کردند.

  • Recruitment centers

    #1
    Name of recruitment center - English: Shahid Motahari Clinic in Shiraz
    Name of recruitment center - Persian: درمانگاه شهید مطهری شیراز
    Full name of responsible person - English: Dr. nasrin asadi
    Full name of responsible person - Persian: دکتر نسرین اسدی
    Street address - English: Namazi Square Clinic of Shahid Motahari
    Street address - Persian: میدان نمازی درمانگاه شهید مطهری
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: ۷۱۳۴۸-۷۱۴۷۳۷
    Phone: +98 71 3612 1000
    Fax: +98 71 3647 4673
    Email: motahari@sums.ac.ir
    Web page address:
    Name of recruitment center - English: Shahid Motahari Clinic in Shiraz
    Name of recruitment center - Persian: درمانگاه شهید مطهری شیراز
    Full name of responsible person - English: Dr. Nasrin Asadi
    Full name of responsible person - Persian: دکتر نسرین اسدی
    Street address - English: Namazi Square Clinic of Shahid Motahari
    Street address - Persian: میدان نمازی درمانگاه شهید مطهری
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: ۷۱۳۴۸-۷۱۴۷۳۷
    Phone: +98 71 3612 1000
    Fax: +98 71 3647 4673
    Email: Motahari@sums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: dr.gholamreza hatam
    Full name of responsible person - Persian: دکتر غلامرضا حاتم
    Street address - English: zand street
    Street address - Persian: شیراز-خیابان زند- دانشگاه علوم پزشکی شیراز
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7134814336
    Phone: +98 71 3725 1006
    Fax:
    Email: Ekramzadeh@sums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr.Gholamreza Hatam
    Full name of responsible person - Persian: دکتر غلامرضا حاتم
    Street address - English: Zand Street
    Street address - Persian: شیراز-خیابان زند- دانشگاه علوم پزشکی شیراز
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7134814336
    Phone: +98 71 3725 1006
    Fax:
    Email: Ekramzadeh@sums.ac.ir
    Web page address:

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
Due to some changes that we had to make while working in the project method.
Acronym
IRCT registration information
IRCT registration number: IRCT20100223003408N7
Registration date: 2020-02-23, 1398/12/04
Registration timing: retrospective

Last update: 2022-07-11, 1401/04/20
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
2018-04-28, 1397/02/08
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

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
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