Protocol summary
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Study aim
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Effect of Vitamin D on Norpathetic Disease in Patients with Type 2 Diabetes
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Design
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This was an experimental trial single (before-after) to compare the effectiveness of 50000 units of vitamin D orally/weekly for 12 on diabetic neuropathy. 60 patients (ages 40 to 65 years old), With diagnosis of diabetic neuropathy (through physical examination and earning more than 4 points from Michigan script and not taking supplemental medications and vitamin D in the last 6 months, lack of kidney and liver failure, arthritic inflammatory diseases, rheumatoid arthritis, hyperthyroidism , Malnutrition, and not pregnant are selected and randomly divided into two groups of study and control.
The study group receives 50,000 units of vitamin D in 12 weeks orally. In the control group, patients receive a placebo.the severity of neuropathy, Vitamin D and HbA1C will be assessed at baseline and 3 months after the initiation of trial.
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Settings and conduct
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before-after
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Participants/Inclusion and exclusion criteria
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ages 40 to 65 years old, diagnosis of diabetic neuropathy
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Intervention groups
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The study group receives 50,000 units of vitamin D in 12 weeks orally
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Main outcome variables
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severity of neuropathy; vitamin D; HbA1C
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:
IRCT2017102325266N2
Registration date:
2017-11-08, 1396/08/17
Registration timing:
registered_while_recruiting
Last update:
2018-07-27, 1397/05/05
Update count:
1
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Registration date
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2017-11-08, 1396/08/17
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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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Vice chancellor for research, YazdUniversity of Medical Sciences
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Expected recruitment start date
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2017-11-06, 1396/08/15
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Expected recruitment end date
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2018-05-05, 1397/02/15
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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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Comparing the effectiveness of 50000 units of vitamin D orally/weekly for 12 weeks and control group on diabetic neuropathy- before and after study
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Public title
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The effectiveness of vitamin D on diabetic neuropathy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Type 2 diabetes,
having a medical record at the Yazd diabetes research center,
willingness to participate in the study,
diagnosis of diabetic neuropathy through physical examination and obtaining a score of more than 4 from the Michigan Neuropathy Screening Questionnaire Instrument (MNSI)
aged 40-60 years old,
Exclusion criteria:
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Age
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From 40 years old to 65 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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No information
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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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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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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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2017-06-20, 1396/03/30
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Ethics committee reference number
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IR.SSU.REC.1396.71
Health conditions studied
1
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Description of health condition studied
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Diabetic neuropathy
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ICD-10 code
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E11
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ICD-10 code description
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Non-insulin-dependent diabetes mellitus
Primary outcomes
1
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Description
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The severity of diabetic neuropathy
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Timepoint
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Before the intervention, After the intervention
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Method of measurement
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Michigan Neuropathy Screening Instrument (MNSI)
2
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Description
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Vitamin D
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Timepoint
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Before the intervention, After the intervention
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Method of measurement
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Blood Test
Secondary outcomes
1
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Description
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HbA1C
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Timepoint
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Before the intervention, After the intervention
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Method of measurement
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Blood Test
Intervention groups
1
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Description
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Subjects receive 50,000 units of vitamin D per week per week for 12 weeks during the intervention period.
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Category
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Treatment - Drugs
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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Yazd 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The total potential data can be shared after unidentifiable participant
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When the data will become available and for how long
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6 months after publication
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To whom data/document is available
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people working in academic institutions
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Under which criteria data/document could be used
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Confidential raw data for secondary analysis will be available to researchers.
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From where data/document is obtainable
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Ghadiri-Anari Akram
09133534621
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What processes are involved for a request to access data/document
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Submit a proposal from prestigious academic institution
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Comments
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