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Effects of vitamin D supplementation compared with the placebo on metabolic profiles, inflammatory factors and biomarkers of oxidative stress in patients with diabetic foot

 View older revisions Content changed at 2019-09-16, 1398/06/25

Protocol summary

Study aim
The aim of this study is to determine the effects of vitamin D supplementation on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in patients with diabetic foot.
Design
Parallel double-blind (both patients and researchers) randomized controlled clinical trial
Settings and conduct
Sixty patients with diabetic foot of eligible and referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
Participants/Inclusion and exclusion criteria
Patients with diabetic foot according to Wagner criteria aged 40 to 85 years will be included in this study.
Intervention groups
Patients will be assigned to receive either vitamin D supplements (intervention group: n=30) or placebo (control group: n=30).
Main outcome variables
Fasting plasma glucose, lipid profiles, inflammatory factors, oxidative stress, and mean ulcer area

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT201510315623N54
Registration date: 2015-11-04, 1394/08/13
Registration timing: registered_while_recruiting

Last update: 2019-09-16, 1398/06/25
Update count: 1
Registration date
2015-11-04, 1394/08/13
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2015-11-01, 1394/08/10
Expected recruitment end date
2015-12-01, 1394/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of vitamin D supplementation compared with the placebo on metabolic profiles, inflammatory factors and biomarkers of oxidative stress in patients with diabetic foot
Public title
Effects of supplementation in the treatment of diabetic foot
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diabetic foot ulcer Aged 40 to 85 years
Exclusion criteria:
Diabetic foot ulcer with grade 3 Pregnant and breastfeeding patients Participants who consumed vitamin D supplements during the past 3 months Anticipated changes in medications throughout the study Patients with history of diseases which influence the development of diabetic foot ulcer including chronic trauma
Age
From 40 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either vitamin D supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
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 Shahid Beheshti 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
Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2015-10-28, 1394/08/06
Ethics committee reference number
IR.Kaums.REC.1394.92

Health conditions studied

1

Description of health condition studied
Diabetic foot
ICD-10 code
E14.5
ICD-10 code description
With peripheral circulatory complications

Primary outcomes

1

Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula

2

Description
Healing of diabetic foot ulcer
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Decrease of the wound size relative to original size: ulcer length (cm), ulcer width (cm), Ulcer depth (cm)

Secondary outcomes

1

Description
Fasting blood sugar
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

2

Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

3

Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

4

Description
HDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

5

Description
Total antioxidant
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

6

Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

7

Description
hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

8

Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

9

Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

10

Description
Vitamin D
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit

11

Description
HbA1c
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Biochemical kit

12

Description
LDL-cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit

13

Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry

Intervention groups

1

Description
Intervention group: Vitamin D capsule, 50000 IU, every 2 weeks for 12 weeks orally.
Category
Treatment - Drugs

2

Description
Control group: Placebo capsule, every week for 12 weeks orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti Clinic
Full name of responsible person
Reza Razzaghi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0026
Email
beheshti@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 2999
Email
research@kaums.ac.ir
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
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
address Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5562 0608
Email
asemi_r@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
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 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
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 5546 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

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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