Protocol summary
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Study aim
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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.
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Design
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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)
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2018-08-15, 1397/05/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-01-14, 1396/10/24
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Expected recruitment end date
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2018-01-30, 1396/11/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Effect of vitamin D supplementation in treatment of diabetic hemodialysis patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-01-13, 1396/10/23
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1396.87
Health conditions studied
1
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Description of health condition studied
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Hemodialysis
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ICD-10 code
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N18
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ICD-10 code description
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Chronic kidney disease (CKD)
Primary outcomes
1
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Description
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Expressed levels of PPAR-γ gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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RT-PCR
Secondary outcomes
1
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Description
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Expressed levels of LDLR gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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RT-PCR
2
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Description
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Expressed levels of GLUT4 gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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RT-PCR
3
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Description
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Expressed levels of IRS1 gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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RT-PCR
4
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Description
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Expressed levels of IRS2 gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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RT-PCR
5
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Description
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Expressed levels of LP (α) gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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RT-PCR
6
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Description
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Expressed levels of PDK1 gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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RT-PCR
7
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Description
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Expressed levels of PI3K gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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RT-PCR
8
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Description
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Expressed levels of PKC gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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RT-PCR
Intervention groups
1
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Description
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Intervention group: 50000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), for 12 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo (Barij Essence, Kashan, Iran) every 2 weeks, for 12 weeks orally.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available