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Protocol summary
From 92 people with type 2 diabetes up to 5 years with diabetes and using metformin medication referred to Khomein health centers and consenting to participate in drug intervention plan Taken fast blood sample. And subjects were randomly divided into four groupswith preservation routine and normal mobility and dietary habits.
First, 12 hours fasting blood samples are taken before starting supplements, and serum is stored at -70 ° C for subsequent analysis.
After a 4-month period of supplementation , 12-hour fasting blood taken again and serum will be kept at -70 ° C for subsequent analysis.
After the intervention period, homocysteine levels were measured by HPLC
From 92 people with type 2 diabetes up to 5 years with diabetes and using metformin medication referred to Khomein health centers and consenting to participate in drug intervention plan Taken fast blood sample. And subjects were randomly divided into four groupswith preservation routine and normal mobility and dietary habits.
First, 12 hours fasting blood samples are taken before starting supplements, and serum is stored at -70 ° C for subsequent analysis.
After a 16 weeks period of supplementation , 12-hour fasting blood taken again and serum will be kept at -70 ° C for subsequent analysis.
After the intervention period, homocysteine levels were measured by HPLC
From 92 people with type 2 diabetes up to 5 years with diabetes and using metformin medication referred to Khomein health centers and consenting to participate in drug intervention plan Taken fast blood sample. And subjects were randomly divided into four groupswith preservation routine and normal mobility and dietary habits. First, 12 hours fasting blood samples are taken before starting supplements, and serum is stored at -70 ° C for subsequent analysis. After a 4-month16 weeks period of supplementation , 12-hour fasting blood taken again and serum will be kept at -70 ° C for subsequent analysis. After the intervention period, homocysteine levels were measured by HPLC
از 92 نفر افراد مبتلا به دیابت نوع 2 حداکثر با 5 سال ابتلا به دیابت و با مصرف دارو متفورمین که به مراکز درمانی شهر خمین مراجعه کردند و رضایت به شرکت در طرح مداخله دارویی دارند نمونه خون ناشتا گرفته می شود و افراد به صورت تصادفی به چهار گروه با حفظ عادات غذایی و تحرک بدنی روتین و نرمال تقسیم شدند، در ابتدا قبل از آغاز مصرف مکملها از افراد نمونه خون ناشتا 12 ساعته گرفته میشود سرم در 70- درجه سانتیگراد برای آنالیزهای بعدی نگه داری میشوند. پس از یک دوره 4ماهه استفاده از مکملهای مجددا نمونه گیری خون ناشتا 12 ساعته صورت خواهد گرفت و سرم در 70- درجه سانتیگراد برای آنالیزهای بعدی نگه داری میشوند. پس از اتمام دوره مداخله میزان هموسیستئین با HPLC سنجش میشود
از 92 نفر افراد مبتلا به دیابت نوع 2 حداکثر با 5 سال ابتلا به دیابت و با مصرف دارو متفورمین که به مراکز درمانی شهر خمین مراجعه کردند و رضایت به شرکت در طرح مداخله دارویی دارند نمونه خون ناشتا گرفته می شود و افراد به صورت تصادفی به چهار گروه با حفظ عادات غذایی و تحرک بدنی روتین و نرمال تقسیم شدند، در ابتدا قبل از آغاز مصرف مکملها از افراد نمونه خون ناشتا 12 ساعته گرفته میشود سرم در 70- درجه سانتیگراد برای آنالیزهای بعدی نگه داری میشوند. پس از یک دوره 16 هفته استفاده از مکملهای مجددا نمونه گیری خون ناشتا 12 ساعته صورت خواهد گرفت و سرم در 70- درجه سانتیگراد برای آنالیزهای بعدی نگه داری میشوند. پس از اتمام دوره مداخله میزان هموسیستئین با HPLC سنجش میشود
از 92 نفر افراد مبتلا به دیابت نوع 2 حداکثر با 5 سال ابتلا به دیابت و با مصرف دارو متفورمین که به مراکز درمانی شهر خمین مراجعه کردند و رضایت به شرکت در طرح مداخله دارویی دارند نمونه خون ناشتا گرفته می شود و افراد به صورت تصادفی به چهار گروه با حفظ عادات غذایی و تحرک بدنی روتین و نرمال تقسیم شدند، در ابتدا قبل از آغاز مصرف مکملها از افراد نمونه خون ناشتا 12 ساعته گرفته میشود سرم در 70- درجه سانتیگراد برای آنالیزهای بعدی نگه داری میشوند. پس از یک دوره 4ماهه16 هفته استفاده از مکملهای مجددا نمونه گیری خون ناشتا 12 ساعته صورت خواهد گرفت و سرم در 70- درجه سانتیگراد برای آنالیزهای بعدی نگه داری میشوند. پس از اتمام دوره مداخله میزان هموسیستئین با HPLC سنجش میشود
(I) placebo of vitamin D one tablet/ week (n=23),
(II) vitamin D3 supplement at a dosage of 50000 IU/ week (n=23).
(III) CrPic supplement at a dosage of 500 µg/day (n=23).
(IV) both vitamin D3 at a dosage of 50000 IU/ week and CrPic at a dosage of 500 µg/day (n=23) for four months.
(I) placebo of vitamin D one tablet/ week (n=23),
(II) vitamin D3 supplement at a dosage of 50000 IU/ week (n=23).
(III) CrPic supplement at a dosage of 500 µg/day (n=23).
(IV) both vitamin D3 at a dosage of 50000 IU/ week and CrPic at a dosage of 500 µg/day (n=23) for 16 weeks.
(I) placebo of vitamin D one tablet/ week (n=23), (II) vitamin D3 supplement at a dosage of 50000 IU/ week (n=23). (III) CrPic supplement at a dosage of 500 µg/day (n=23). (IV) both vitamin D3 at a dosage of 50000 IU/ week and CrPic at a dosage of 500 µg/day (n=23) for four months16 weeks.
گروه اول: دریافت دارونما و به عنوان گروه کنترل
گروه دوم: دریافت ویتامین دی 50000 IUبه صورت هفتگی یک عدد قرص
گروه سوم: دریافت کروم 500 µgبه صورت روزانه یک عدد قرص
گروه چهارم: دریافت کروم و ویتامین دی
برای 4 ماه
گروه اول: دریافت دارونما و به عنوان گروه کنترل
گروه دوم: دریافت ویتامین دی 50000 IUبه صورت هفتگی یک عدد قرص
گروه سوم: دریافت کروم 500 µgبه صورت روزانه یک عدد قرص
گروه چهارم: دریافت کروم و ویتامین دی
برای 16 هفته
گروه اول: دریافت دارونما و به عنوان گروه کنترل گروه دوم: دریافت ویتامین دی 50000 IUبه صورت هفتگی یک عدد قرص گروه سوم: دریافت کروم 500 µgبه صورت روزانه یک عدد قرص گروه چهارم: دریافت کروم و ویتامین دی برای 4 ماه16 هفته
General information
2019-12-22, 1398/10/01
2017-08-30, 1396/06/08
20192017-1208-2230 00:00:00
2020-09-20, 1399/06/30
2018-01-30, 1396/11/10
20202018-0901-2030 00:00:00
empty
Homocysteine assay is performed on 300 μl of additional sample of previous study with code IRCT2017052034038N1, stored at -80 C0. There is no need to re-bleeding
Homocysteine assay is performed on 300 μl of additional sample of previous study with code IRCT2017052034038N1, stored at -80 C0. There is no need to re-bleeding
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سنجش هموسیستئین بر روی 300 میکرولیتر از نمونه اضافی مطالعه قبلی با کد IRCT2017052034038N1 انجام می شود که در یخچال -80 درجه ذخیره شده بود و نیازی به خون گیری مجدد از بیماران نیست
سنجش هموسیستئین بر روی 300 میکرولیتر از نمونه اضافی مطالعه قبلی با کد IRCT2017052034038N1 انجام می شود که در یخچال -80 درجه ذخیره شده بود و نیازی به خون گیری مجدد از بیماران نیست
Intervention groups
#1
Intervention group: PLACEBO,CELLEROS,One pill per week, for 4 months,Orally
Intervention group: PLACEBO,CELLEROS,One pill per week, for 16 weeks months,Orally
Intervention group: PLACEBO,CELLEROS,One pill per week, for 416 weeks months,Orally
گروه مداخله اول: دریافت دارونما ، سلولز، 1 قرص در هر هفته، 4 ماه، به صورت خوراکی،
گروه مداخله اول: دریافت دارونما ، سلولز، 1 قرص در هر هفته، 16 هفته، به صورت خوراکی،
گروه مداخله اول: دریافت دارونما ، سلولز، 1 قرص در هر هفته، 4 ماه16 هفته، به صورت خوراکی،
#2
Intervention group:vitamin D, One pill per week, for 4 months,Orally
Intervention group:vitamin D, One pill per week, for 16 weeks,Orally
Intervention group:vitamin D, One pill per week, for 4 months,Orally16 weeks,Orally
گروه مداخله دوم: ویتامین دی، یک قرص در هر هفته، 4 ماه، بصورت خوراکی
گروه مداخله دوم: ویتامین دی، یک قرص در هر هفته، 16 هفته بصورت خوراکی
گروه مداخله دوم: ویتامین دی، یک قرص در هر هفته، 4 ماه،16 هفته بصورت خوراکی
#3
Intervention group: chromium picolinate, One pill per day, for 4 months, Orally
Intervention group: chromium picolinate, One pill per day, for 16 weeks, Orally
Intervention group: chromium picolinate, One pill per day, for 4 months16 weeks, Orally
گروه مداخله سوم: پیکولینات کروم، یک قرص در هر روز، برای 4 ماه، به صورت خوراکی
گروه مداخله سوم: پیکولینات کروم، یک قرص در هر روز، برای 16 هفته، به صورت خوراکی
گروه مداخله سوم: پیکولینات کروم، یک قرص در هر روز، برای 4 ماه16 هفته، به صورت خوراکی
#4
Intervention group four: chromium picolinate and vitamin D, One pill per day for chromium picolinate and One pill per week for vitamin D , for 4 months, Orally
Intervention group four: chromium picolinate and vitamin D, One pill per day for chromium picolinate and One pill per week for vitamin D , for 16 weeks , Orally
Intervention group four: chromium picolinate and vitamin D, One pill per day for chromium picolinate and One pill per week for vitamin D , for 4 months16 weeks , Orally
گروه مداخله چهارم: پیکولینات کروم و ویتامین دی، پیکولینات کروم هر روز و ویتامین دی هر هفته یک قرص، به مدت 4ماه، خوراکی
گروه مداخله چهارم: پیکولینات کروم و ویتامین دی، پیکولینات کروم هر روز و ویتامین دی هر هفته یک قرص، به مدت16 هفته، خوراکی
گروه مداخله چهارم: پیکولینات کروم و ویتامین دی، پیکولینات کروم هر روز و ویتامین دی هر هفته یک قرص، به مدت 4ماهمدت16 هفته، خوراکی
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Deputy of Research and Technology
Full name of responsible person - Persian: معاون تحقیقات و فناوری
Street address - English: Arak, Sardasht, Basij Square, Prophet's Complex -
Street address - Persian: اراک، سردشت، میدان بسیج، مجتمع پیامبر اعظم
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 0098-34173505
Phone: +98 86 3417 3505
Fax:
Email: fimaniran64@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Alireza Kamali
Full name of responsible person - Persian: دکتر علیرضا کمالی
Street address - English: Arak university of medical sciences, Basij Square, Arak
Street address - Persian: اراک، میدان بسیج، دانشگاه علوم پزشکی اراک
City - English: Arak
City - Persian: اراک
Province: Markazi
Country: Iran (Islamic Republic of)
Postal code: 0098-34173505
Phone: +98 86 3417 3505
Fax:
Email: fimaniran64@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Deputy of Research and TechnologyDr. Alireza Kamali Full name of responsible person - Persian: معاون تحقیقات و فناوریدکتر علیرضا کمالی Street address - English: Arak, Sardasht university of medical sciences, Basij Square, Prophet's Complex -Arak Street address - Persian: اراک، سردشت، میدان بسیج، مجتمع پیامبر اعظمدانشگاه علوم پزشکی اراک City - English: Arak City - Persian: اراک Province: Markazi Country: Iran (Islamic Republic of) Postal code: 0098-34173505 Phone: +98 86 3417 3505 Fax: Email: fimaniran64@gmail.com Web page address:
Protocol summary
Study aim
Evaluation and comparison of the effects of simultaneous use of chromium and vitamin D supplementation on homocysteine levels in patients with type 2 diabetes
Design
A randomized, double-blind, placebo-controlled clinical trial.92 patients with type 2 diabetes were randomly assigned into 4 groups, numbered 1 to 92.
Settings and conduct
From 92 people with type 2 diabetes up to 5 years with diabetes and using metformin medication referred to Khomein health centers and consenting to participate in drug intervention plan Taken fast blood sample. And subjects were randomly divided into four groupswith preservation routine and normal mobility and dietary habits.
First, 12 hours fasting blood samples are taken before starting supplements, and serum is stored at -70 ° C for subsequent analysis.
After a 16 weeks period of supplementation , 12-hour fasting blood taken again and serum will be kept at -70 ° C for subsequent analysis.
After the intervention period, homocysteine levels were measured by HPLC
Participants/Inclusion and exclusion criteria
Inclusion criteria: Includes patients with type 2 diabetes for at least 5 years with diabetes and metformin use in the age range 25-60 years.
Exclusion criteria included those with 1) insulin injection 2) inflammatory diseases 3) kidney disease 4) liver disease 5) parathyroid disease 6) pregnancy and lactation 7) anticonvulsant and steroid use 8) history of use Tobacco 9) Use of vitamins and minerals 10) Patients with hyperthyroidism and hypothyroidism.
Intervention groups
(I) placebo of vitamin D one tablet/ week (n=23),
(II) vitamin D3 supplement at a dosage of 50000 IU/ week (n=23).
(III) CrPic supplement at a dosage of 500 µg/day (n=23).
(IV) both vitamin D3 at a dosage of 50000 IU/ week and CrPic at a dosage of 500 µg/day (n=23) for 16 weeks.
Main outcome variables
Homocysteine levels
General information
Reason for update
Homocysteine assay is performed on 300 μl of additional sample of previous study with code IRCT2017052034038N1, stored at -80 C0. There is no need to re-bleeding
Acronym
IRCT registration information
IRCT registration number:IRCT20190610043852N1
Registration date:2019-10-21, 1398/07/29
Registration timing:retrospective
Last update:2020-01-14, 1398/10/24
Update count:1
Registration date
2019-10-21, 1398/07/29
Registrant information
Name
Fatemeh Imanparast
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
fimaniran64@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-30, 1396/06/08
Expected recruitment end date
2018-01-30, 1396/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of the simultaneous use of chromium and vitamin D supplements on hemosysteien in type 2 diabetes
Public title
effects of chromium and vitamin D supplements on hemosysteien in type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes for at least 5 years.
In the age range of 25-60 years
6 months before the onset of study did not change the hypoglycemic drugs and remained stable during study.
Exclusion criteria:
not inject insulin.
Does not have severe inflammatory disease, kidney disease, liver disease, parathyroid disease, hyper and hypothyroidism
didn't take any vitamin and mineral supplements 6 months prior to the study
Has no history of using anticonvulsants, steroids, and tobacco in the past 6 months.
Age
From 25 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Crash, Individual Crash Unit, Random Number Table Crash Tool.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, none of the patients not aware in the placebo group because placebo is similar to vitamin D supplement. Also the data analyzer does not know What supplement each group received. In fact, the data is given to the analyzer for analysis in 4 groups of 1 to 4.
Placebo
Used
Assignment
Parallel
Other design features
not
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Square, Arak
City
Arak
Province
Markazi
Postal code
0098-34173505
Approval date
2019-05-22, 1398/03/01
Ethics committee reference number
IR.ARAKMU.REC.1398.131
Health conditions studied
1
Description of health condition studied
diabets
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Homocysteine
Timepoint
before intervention, after intervention
Method of measurement
HPLC
Secondary outcomes
1
Description
Weight
Timepoint
Before and after the interference
Method of measurement
scale
2
Description
Height
Timepoint
Before and after the interference
Method of measurement
metr
3
Description
blood pressure
Timepoint
Before and after the interference
Method of measurement
pressure indicator
Intervention groups
1
Description
Intervention group: PLACEBO,CELLEROS,One pill per week, for 16 weeks months,Orally
Category
Placebo
2
Description
Intervention group:vitamin D, One pill per week, for 16 weeks,Orally
Category
Treatment - Other
3
Description
Intervention group: chromium picolinate, One pill per day, for 16 weeks, Orally
Category
Treatment - Other
4
Description
Intervention group four: chromium picolinate and vitamin D, One pill per day for chromium picolinate and One pill per week for vitamin D , for 16 weeks , Orally
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Fatemeh Imanparast
Street address
Beheshti Boulevard
City
Khomein
Province
Markazi
Postal code
0098-46224142
Phone
+98 86 4622 4142
Email
fimaniran64@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Alireza Kamali
Street address
Arak university of medical sciences, Basij Square, Arak
City
Arak
Province
Markazi
Postal code
0098-34173505
Phone
+98 86 3417 3505
Email
fimaniran64@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of Research and Technology
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
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Imanparast
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
- Complex of the Great Prophet, Basij Square,Sardasht
City
Arak
Province
Markazi
Postal code
0098-34173505
Phone
+98 86 4622 4142
Email
fimaniran64@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Imanparast
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Arak university OF medical sciences, Basij Square, Arak -
City
Arak
Province
Markazi
Postal code
0098-34173505
Phone
+98 86 3417 3505
Email
fimaniran64@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Imanparast
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Arak University of Medical Sciences, Basij Square, Arak
City
Arak
Province
Markazi
Postal code
6941738481
Phone
+98 86 3417 3505
Email
fimaniran64@gmail.com
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
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