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Effect of vitamin D on Insulin requirement in children with diabetes type 1 and vitamin D deficiency

Protocol summary

Summary
objective: In this clinical trial the effect of vitamin D Supplementation on insulin dose in diabetic children will be evaluated. Design: The Sample included 60 children aged 5 to 15 years with type I diabetes presenting to pediatric endocrinology clinic. Setting and participants: Within the first visit, Height, weight, Blood pressure and maturity status are evaluated. Serum levels of 25 (OH) D , TSH, Ca, p, Alkp and HbA1C will be measured. In diabetic cases who have Vitamin D deficiency or insufficiency, dose of insulin will be measured. Inclusion major eligibility criteria: children with type 1 diabetes and vitamin D deficiency. Exclusion criteria: Vitamin D supplementation in the last 6 months Intervention:In the second phase,cases with insufficient levels of vitamin D or vitamin D deficiency are treated with 50,000 IU of vitamin D Pearl 10 per week to 10 weeks and again, after the end of treatment,serum levels of vitamin D and HbA1C and insulin dose will be evaluated.Main outcome measure variables:If this study clinically and statistically lead to significant results, Vitamin D can be measured in diabetic children and with treatment in the event of vitamin D deficiency,decrease insulin intake and in long time can reduce the financial burden on the families of people with diabetes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014120111799N3
Registration date: 2015-03-14, 1393/12/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-03-14, 1393/12/23
Registrant information
Name
Zahra Alian
Name of organization / entity
Sciences Hamedan University of Medical
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0063
Email address
z.alian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research And Technology
Expected recruitment start date
2014-06-21, 1393/03/31
Expected recruitment end date
2015-08-22, 1394/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D on Insulin requirement in children with diabetes type 1 and vitamin D deficiency
Public title
Effect of vitamin D on Insulin requirement
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion Criteria: 1)Diabetic cases 5-15 years old that referred to endocrinology clinic 2)6 months after the diagnosis of type 1 diabetes Exclusion Criteria: 1) Vitamin D supplementation in the last 6 months 2) The simultaneous existence of associated diseases (hypothyroidism) 3) Lack of cooperation 4) Regime change in the treatment of diabetes
Age
From 5 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hamedan University Of Medical Sciences
Street address
Shahid Fahmide Street
City
Hamedan
Postal code
Approval date
2015-01-24, 1393/11/04
Ethics committee reference number
5433/9/35/16/پ

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E10-E11-E1
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
Insulin Dose
Timepoint
Before intervention, 3 Months after the intervention
Method of measurement
Unit/ Syrange Insulin 100 unit/ penfile insulin

Secondary outcomes

1

Description
Blood Glucose
Timepoint
Before intervention,3 months after the intervention
Method of measurement
mg/dl/ECL method

Intervention groups

1

Description
Pearl Vitamin D3,50000 unit,Manufacturing of Razi Pharmaceutical Company,each week one for 10 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Clinic
Full name of responsible person
Zahra Alian
Street address
Pediatric Ward 2, Besat Hospital
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research, Hamedan University of Medical Sciences
Full name of responsible person
Doctor Saeed Bashirian
Street address
Shahid Fahmideh Blvd, Medicine School
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, Hamedan 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
School Of Medicine,Sciences Hamedan University Of Medical
Full name of responsible person
Zahra Alian
Position
Assistant
Other areas of specialty/work
Street address
Pediatric Ward 2, Besat Hospital, Motahari Blvd.
City
Hamedan
Postal code
Phone
+98 31 3264 0064
Fax
Email
z_alian@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School Of Medicine,Sciences Hamedan University Of Medical
Full name of responsible person
Zahra Alian
Position
Assistant
Other areas of specialty/work
Street address
Pediatric Ward 2,Besat Hospital,Motahari Blvd.
City
Hamedan
Postal code
Phone
+98 81 3264 0064
Fax
Email
z_alian@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Medicine, Sciences Hamedan University Of Medical
Full name of responsible person
Zahra Alian
Position
Assistant
Other areas of specialty/work
Street address
Pediatric Ward 2, Besat Hospital, Motahari Blvd.
City
Hamedan
Postal code
Phone
+98 81 3264 0064
Fax
Email
z_alian@yahoo.com
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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