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Randomized, double blinded, case-control clinical trial on effect of vitamin D supplementation on metabolic profiles in diabetic Hemodialysis patients

Protocol summary

Summary
Objectives Aim of this study is to determine the effects of vitamin D supplementation on lipid profiles, insulin sensitivity, inflammatory and stress oxidative biomarkers in diabetic hemodialysis patients. Inclusion and Exclusion Criteria Diabetic hemodialysis patients with glomerular filtration rate less than 10 ml per minute, or less than 25 ml per minute with malnutrition or hyperkalemia will enroll. All patients with overt diabetes mellitus, smoking, hypo or hyperthyroidism, any condition that need to hospitalization and hypertension (systolic pressure higher than 160 and diastolic pressure of 100 mm Hg) exclude from the study. Patients and Sample Size Seventy diabetic hemodialysis patients enroll in is a case-control, double blinded, randomized clinical trial, Phase 3, after informed consent and are randomly divided into two groups, and then interventions will conduct. Interventions In the intervention group, patients will receive pearl of vitamin D, 50000 IU weekly for 12 weeks. The control group will receive placebo for 12 weeks. Main outcome variables The main outcome variables are insulin metabolism markers, lipid profiles, inflammatory bio-markers and oxidative stress.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017040924625N4
Registration date: 2017-05-11, 1396/02/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-11, 1396/02/21
Registrant information
Name
Mehrdad Zahmatkesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7844
Email address
mehrdadzahmatkesh@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research, Semnan University of Medical Sciences and Health Services
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2018-04-03, 1397/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized, double blinded, case-control clinical trial on effect of vitamin D supplementation on metabolic profiles in diabetic Hemodialysis patients
Public title
The effect of vitamin D supplementation in diabetic dialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Hemodialysis patients with malnutrition or hyperkalemia; Diabetes mellitus. Exclusion criteria: Overt Diabetes; Smoking; Hypothyroidism or hyperthyroidism; Any disease that need to hospitalization; Hypertension
Age
From 45 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Basidj Boulevard
City
Semnan
Postal code
Approval date
2016-11-08, 1395/08/18
Ethics committee reference number
IR.SEMUMS.REC.1395.144

Health conditions studied

1

Description of health condition studied
vitamin D supplementation in hemodialysis
ICD-10 code
Z49.0
ICD-10 code description
Preparatory care for dialysis

Primary outcomes

1

Description
insulin metabolism markers
Timepoint
At the first and end of study (3 months period)
Method of measurement
Laboratory tests and mathematical calculations

Secondary outcomes

1

Description
oxidative stress
Timepoint
At the first and end of study (3 months period)
Method of measurement
Laboratory tests

2

Description
inflammatory biomarkers
Timepoint
At the first and end of study (3 months period)
Method of measurement
Laboratory tests

3

Description
lipid profiles
Timepoint
At the first and end of study (3 months period)
Method of measurement
Laboratory tests

Intervention groups

1

Description
The intervention group will receive pearl of vitamin D, 50000 IU weekly for 12 weeks. Patients encourage to do not change their normal physical activity in this period.
Category
Treatment - Drugs

2

Description
The intervention group will receive placebo pearl similar to vitamin D pearl for 12 weeks. Patients encourage to do not change their normal physical activity in this period.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Akhevan Hospital
Full name of responsible person
De. Ali Reza Soleymani
Street address
City
Kashan

2

Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Dr. Mohammad Reza Tamadon
Street address
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Asgari
Street address
Basidj Boulevard
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Tamadon
Position
Nephrologist
Other areas of specialty/work
Street address
Amin Boulevard, Kowsar Hospital
City
Semnan
Postal code
Phone
+98 23 3142 2120
Fax
Email
mrt_tamadon@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Tamadon
Position
Nephrologist
Other areas of specialty/work
Street address
Amin Boulevard, Kowsar Hospital
City
Semnan
Postal code
Phone
+98 23 3142 2120
Fax
Email
mrt_tamadon@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkes
Position
Researchman
Other areas of specialty/work
Street address
Amin Boulevard, Kowsar Hospital
City
Semnan
Postal code
Phone
+98 23 3142 2120
Fax
Email
mehrdadzahmatkesh@semums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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