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The effects of vitamin D supplementation compared with the placebo on gene expression related to insulin and lipid in diabetic hemodialysis patients

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History
# Registration date Revision Id
2 2019-09-29, 1398/07/07 105766
1 2018-08-15, 1397/05/24 56447
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  • Protocol summary

    طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. تصادفی سازی با استفاده از جدول اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. بیماران به دو گروه برای دریافت مکمل ویتامین دی (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد.
    طراحي انجام مطالعه: کارآزمایی بالینی دو سوکور کنترل شده با دارونما. تصادفی سازی با استفاده از اعداد تصادفی ایجاد شده توسط کامپیوتر انجام خواهد شد. بیماران به دو گروه برای دریافت مکمل ویتامین دی (30=n) یا پلاسبو (30=n) اختصاص داده خواهند شد.
    Among diabetic hemodialysis patients referred to Akhavan Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
    Among diabetic hemodialysis patients referred to Kosar Clinic affiliated to Semnan University of Medical Sciences, Semnan, Iran, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
    از بین بیماران همودیالیزی دیابتیک ارجاع شده به کلینیک اخوان وابسته به دانشگاه علوم پزشکی کاشان، کاشان، ایران، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. کپسول های مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته.
    از بین بیماران همودیالیزی دیابتیک ارجاع شده به کلینیک کوثر وابسته به دانشگاه علوم پزشکی سمنان، سمنان، ایران، 60 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. کپسول های مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و 12 هفته بعد از مداخله از بیماران گرفته خواهد شد. زمان مداخله: 12 هفته.
    Inclusion criteria: diabetic hemodialysis patients aged 18 to 80 years old. Exclusion criteria: unwillingness to cooperate, Hypothyroidism or hyperthyroidism, taking any supplements within 3 months prior to intervention and smokers.
    Inclusion criteria: diabetic hemodialysis patients aged 18 to 80 years old. Exclusion criteria: Taking vitamin D, antioxidant, anti-inflammatory and immunosuppressive drugs during three months before intervention.
    معیارهای ورود: بیماران همودیالیزی دیابتیک در محمدوده سنی سن 18 تا 80 سال. معیار عدم ورود: عدم تمایل به همکاری، کم کاری یا پرکاری تیروئید، مصرف هر نوع مکمل طی 3 ماه قبل از مداخله و سیگاری ها.
    معیارهای ورود: بیماران همودیالیزی دیابتیک در محمدوده سنی سن 18 تا 80 سال. معیار عدم ورود: گرفتن داروهای ویتامین دی، آنتی اکسیدانت، ضد التهابی و سرکوبگر ایمنی در طی سه ماه قبل از مداخله.

  • General information

    2018-02-04, 1396/11/15
    2018-01-30, 1396/11/10
    Inclusion criteria: Diabetic hemodialysis patients.
    Individuals aged 18 to 80 years old
    Patients diabetic hemodialysis
    Individuals aged 18 to 80 years old
    معیارهای ورود: بیماران همودیالیزی دیابتیک
    افراد در محدوده سنی سن 18 تا 80 سال
    بیماران همودیالیزی دیابتیک
    افراد در محدوده سنی سن 18 تا 80 سال
    Exclusion criteria: unwillingness to cooperate
    Hypothyroidism or hyperthyroidism
    Taking any supplements within 3 months prior to intervention
    Smokers
    Taking vitamin D, antioxidant, anti-inflammatory and immunosuppressive drugs during three months before intervention
    معیار عدم ورود: عدم تمایل به همکاری.
    کم کاری یا پرکاری تیروئید
    مصرف هر نوع مکمل طی 3 ماه قبل از مداخله
    سیگاری ها
    مصرف داروهای ویتامین دی، آنتی اکسیدانت، ضد التهابی و سرکوبگر ایمنی طی 3 ماه قبل از مداخله

  • Secondary outcomes

    #1
    Expressed levels of Ox-LDL gene
    Expressed levels of LDLR gene
    سطوح بیان Ox-LDL
    سطوح بیان LDLR
    #2
    empty
    Expressed levels of PKC gene
    empty
    سطوح بیان PKC
    empty
    At the beginning of the study and after 12 weeks of intervention
    empty
    در ابتدای مطالعه و 12 هفته بعد از مداخله
    empty
    RT-PCR
    empty
    RT-PCR

  • Recruitment centers

    #1
    Name of recruitment center - English: Akhavan Hospital in Kashan
    Name of recruitment center - Persian: بیمارستان اخوان کاشان
    Full name of responsible person - English: Dr. Zatallah Asemi
    Full name of responsible person - Persian: دکتر ذات الله عاصمی
    Street address - English: Kashan, 15 Khordad Avenue
    Street address - Persian: کاشان، خیابان 15 خرداد
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 17832445332
    Phone: +98 31 5562 1158
    Fax: +98 31 5562 1158
    Email: hamedir2010@gmail.com
    Web page address:
    Name of recruitment center - English: Kosar Clinic
    Name of recruitment center - Persian: کلینیک کوثر
    Full name of responsible person - English: Mohammd Reza Tamadon
    Full name of responsible person - Persian: محمد رضا تمدن
    Street address - English: Amin Avenue, Gholestan Shahrak, Semnan
    Street address - Persian: سمنان، شهرک گلستان، خیابان امین
    City - English: Semnan
    City - Persian: سمنان
    Province: Semnan
    Country: Iran (Islamic Republic of)
    Postal code: 99951-35198
    Phone: +98 23 3343 7837
    Fax:
    Email: tamadon-mr@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. Gholamali Hamidi
    Full name of responsible person - Persian: دکتر غلامعلی حمیدی
    Street address - English: Ravand
    Street address - Persian: راوند
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 7814111111
    Phone: +98 31 5562 1158
    Fax: +98 31 5562 1158
    Email: hamedir2010@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Gholamali Hamidi
    Full name of responsible person - Persian: دکتر غلامعلی حمیدی
    Street address - English: Ghotbe Ravandi Boulevard, Kashan
    Street address - Persian: کاشان، بلوار قطب راوندی
    City - English: Kashan
    City - Persian: کاشان
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 8115187159
    Phone: +98 31 5562 1158
    Fax: +98 31 5562 1158
    Email: Gholamali.h@gmail.com
    Web page address:

Protocol summary

Study aim
Objective: The aim of this study is to determine the effects of vitamin D supplementation on gene expression related to insulin and lipid in diabetic hemodialysis patients.
Design
Study design: randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive vitamin D supplement (n=30) or placebo (n=30)
Settings and conduct
Among diabetic hemodialysis patients referred to Kosar Clinic affiliated to Semnan University of Medical Sciences, Semnan, Iran, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diabetic hemodialysis patients aged 18 to 80 years old. Exclusion criteria: Taking vitamin D, antioxidant, anti-inflammatory and immunosuppressive drugs during three months before intervention.
Intervention groups
Intervention group: 50000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), for 12 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran) every 2 weeks, for 12 weeks orally.
Main outcome variables
Outcomes: PPAR-γ gene expression levels (primary outcomes) and gene expression related to lipid and insulin (secondary outcomes) will be quantified at study baseline and end-of-trial.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180525039828N1
Registration date: 2018-08-15, 1397/05/24
Registration timing: retrospective

Last update: 2019-09-30, 1398/07/08
Update count: 1
Registration date
2018-08-15, 1397/05/24
Registrant information
Name
Elahe Seyed hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5557 0870
Email address
seyedhosseini-e@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-14, 1396/10/24
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 vitamin D supplementation compared with the placebo on gene expression related to insulin and lipid in diabetic hemodialysis patients
Public title
Effect of vitamin D supplementation in treatment of diabetic hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diabetic hemodialysis Individuals aged 18 to 80 years old
Exclusion criteria:
Taking vitamin D, antioxidant, anti-inflammatory and immunosuppressive drugs during three months before intervention
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
To decrease potential confounding effects, all participants will have stratified randomization according to BMI (<25 and ≥25 kg/m2) and age (<50 and ≥50 y). Then, participants in each block will be randomly allocated into two treatment groups to take either vitamin D supplements or placebo. Randomization will be done by the use of computer softwares.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Akhavan clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2018-01-13, 1396/10/23
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1396.87

Health conditions studied

1

Description of health condition studied
Hemodialysis
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)

Primary outcomes

1

Description
Expressed levels of PPAR-γ gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
RT-PCR

Secondary outcomes

1

Description
Expressed levels of LDLR gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
RT-PCR

2

Description
Expressed levels of GLUT4 gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
RT-PCR

3

Description
Expressed levels of IRS1 gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
RT-PCR

4

Description
Expressed levels of IRS2 gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
RT-PCR

5

Description
Expressed levels of LP (α) gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
RT-PCR

6

Description
Expressed levels of PDK1 gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
RT-PCR

7

Description
Expressed levels of PI3K gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
RT-PCR

8

Description
Expressed levels of PKC gene
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
RT-PCR

Intervention groups

1

Description
Intervention group: 50000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), for 12 weeks orally.
Category
Treatment - Drugs

2

Description
Control group: Placebo (Barij Essence, Kashan, Iran) every 2 weeks, for 12 weeks orally.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar Clinic
Full name of responsible person
Mohammd Reza Tamadon
Street address
Amin Avenue, Gholestan Shahrak, Semnan
City
Semnan
Province
Semnan
Postal code
99951-35198
Phone
+98 23 3343 7837
Fax
Email
tamadon-mr@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5562 1158
Fax
+98 31 5562 1158
Email
Gholamali.h@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5562 1158
Fax
+98 31 5562 1158
Email
asemi_z@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5562 1158
Email
asemi_z@kaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
87147666533
Phone
+98 31 5562 1158
Email
asemi_z@kaums.ac.ir

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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