The main purpose of this study is to survey the supplementation effect of vitamin D on endothelial function in patients with type 1 diabetes. This is a double blind randomized placebo-controlled clinical trial. Ultrasonography will be performed in a single center for the patients who referred from two endocrinologists. Study population includes 72 patients who equally divided to case and control group. Inclusion criteria for the patients are as follows: confirmed type 1 diabetes mellitus, age range of 5 to 20 years old, without vitamin D deficiency (vitamin D level > 30 nmol/L) and disturbed FMD. Patients with HbA1c ≥8%, hepatic dysfunction or malignancy and uncontrolled hypertension will be excluded. Patients in case group will receive 1000 IU of vitamin D every day for 12 weeks. In the same period of time, the placebo will be taken by control group. For the assessment of arterial function, brachial artery diameter of each patient is measured by two radiologists separately. In this regard, FMD will be calculated two times at the initiation (before intervention) and the end (after 12 weeks) of the study period using the following formula: FMD= (D1-D0)/D0 ×100
General information
Acronym
FMD - Flow Mediated Dilatation
IRCT registration information
IRCT registration number:IRCT2016112331062N1
Registration date:2017-01-27, 1395/11/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-01-27, 1395/11/08
Registrant information
Name
zahra mardanshahi
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3325 5348
Email address
mardanshahi56@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazanadarn University of Medical Sciences and Daana Pharmaceutical Company will fund this project
Expected recruitment start date
2017-02-03, 1395/11/15
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Supplementation effect of vitamin D on endothelial function in patients with type 1 diabetes
Public title
The Supplementation effect of vitamin D on arterial function in patients with type 1 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria:
- Confirmed Type 1 diabetes mellitus
- Age range of 5 to 20 years old
- Without vitamin D deficiency (level of 25-hydroxyvitamin D> 30 nmol/L)
- With disturbed FMD (2% change in FMD)
Exclusion Criteria:
- HbA1c ≥ 8%
- Hepatic dysfunction or malignancy
- Uncontrolled hypertension (>140/90 mmHg)
Age
From 5 years old to 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Mazandaran University of Medical Sciences
Street address
Moallem square, Mazandaran University of Medical Sciences
City
Sari
Postal code
Approval date
2016-12-28, 1395/10/08
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.2616
Health conditions studied
1
Description of health condition studied
diabetes mellitus type I
ICD-10 code
E10
ICD-10 code description
diabetes (mellitus): brittle juvenile-onset ketosis-prone type I
Primary outcomes
1
Description
flow mediated dilation of the brachial artery
Timepoint
Initial of the study (Before intervention) and end of the study (After 12 weeks)
Method of measurement
FMD measurement in this study will be done based on ACC guideline. The subject is positioned supine for 10 minutes with the arm in a comfortable position. First, anterior-posterior diameter of the right brachial artery is measured 3-5 centimeter above the antecubital fossa by using a Doppler Ultrasound probe and measurement location will be marked on the skin. For the next step, a sphygmomanometric cuff is placed on the forearm below the arterial scan location. The cuff is inflated to at least 250 mm Hg to occlude arterial inflow for 5 minutes. This causes ischemia of downstream resistance vessels. 45 – 60 seconds after cuff dilation, the longitudinal image of the brachial artery is recorded again on the same location as before to measure its anterior-posterior diameter. In the response to increase blood flow after induced ischemia, brachial artery dilates and this dilation depends on arterial endothelium.
Secondary outcomes
1
Description
Fasting blood sugar
Timepoint
Begining of the study (Before the intervention) and End of the study (48 hours after final medicine usage)
Method of measurement
Blood samples from all patients will be sent to the laboratory for glucose analysis
Intervention groups
1
Description
Patients in the in intervention group will receive 1000 IU of vitamin D every day for 12 weeks.
Category
Treatment - Drugs
2
Description
placebo will be taken by the control group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bouali Sina Hospital
Full name of responsible person
Zahra Mardanshahi
Street address
Bouali Sina hospital, Pasdaran Blvd.
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Daana Pharmaceutical Company
Full name of responsible person
Reza Jalali Milani
Street address
No. 3, 6th block, In front of Tehran clinic, Ghaem Magham Farahani St
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Daana Pharmaceutical Company
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Bagher Montazeri
Street address
Moallem square, Mazandaran University of Medical Sciences
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
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
Mazanadaran University of Medical Sciences
Full name of responsible person
Zahra Mardanshahi
Position
assistant professor of radiology
Other areas of specialty/work
Street address
Imam Khomini hospital, Amir Mazanadarani St.
City
Sari
Postal code
Phone
00
Fax
Email
zmardanshahi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazanadaran university of Medical Scinces
Full name of responsible person
Zahra Mardanshahi
Position
Assistant professor of radiology
Other areas of specialty/work
Street address
Imam Khomeini hospital, Ami mazandarani St.
City
Sari
Postal code
Phone
00
Fax
Email
zmardanshahi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Maryam Tayebi
Position
Research assisstant/ BSc of radiology
Other areas of specialty/work
Street address
Imam Khomieni hospital, Amir mazandarani St.
City
Sari
Postal code
Phone
00
Fax
Email
mary.tayebi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)