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Effect of vitamin D on HbA1c in diabetic patients aged 7-20 years with a vitamin D deficiency

Protocol summary

Summary
In this study, from December 2012 to 2013, first as case-control then interventional study, the aim is evaluation the effect of vitamin D on HbA1c in diabetic patients aged 7-20 years with vitamin D deficiency. Design: Study subjects included 62 consecutive patients with diabetes mellitus type 1 and 62 non-diabetic cases. Setting and conduct: In the first visit, height, weight, blood pressure and puberty state is recorded. The 25OHD levels in both groups and HbA1c levels in diabetic Patients will be measured. Intervention: In all diabetic Patients with insufficient levels of vitamin D or vitamin D deficiency, P, Ca, ALKP and PTH levels will be measured. Then a course of treatment with 50,000 IU of pearl vitamin D per week for ten weeks will be given and again 2 months after completion of treatment these parameters will be checked. Inclusion criteria included all diabetic type 1 Patients aged 7-20 that over the past 5 years have diabetes. Exclusion criteria included use of vitamin D supplements in the last 6 months and associated diseases (hypothyroidism, celiac disease). Main outcome measure:HbA1c levels that 2 months after the end of the intervention will be measured in diabetic Patients. Vitamin D is manufactured by the Farabi pharmaceutical. In control group with vitamin D deficiency,can be treated with pearl vitamin D but these people are not in the intervention phase of our study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013022811799N2
Registration date: 2013-08-07, 1392/05/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-08-07, 1392/05/16
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
Research Assistant Hamedan University of Medical Sciences
Expected recruitment start date
2012-11-20, 1391/08/30
Expected recruitment end date
2013-11-21, 1392/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Effect of vitamin D on HbA1c in diabetic patients aged 7-20 years with a vitamin D deficiency
Public title
Vitamin D effect on the HbA1c in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- All patients aged 7-20 years with type I diabetes 2-Over the past 5 years have diabetes 3- HbA1c level of less than 8 at the time of the study 4-Patients' vitamin D levels measured in the same season. exclusion criteria: 1-Vitamin D supplementation in the last 6 months in patients 2- Simultaneous presence of associated diseases (hypothyroidism, celiac) 3-Obesity and weight gain in the control group 4-Lack of patient cooperation.
Age
From 7 years old to 20 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 62
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
Ethics Committee, School of Medicine, Shahid Fahmide Street
City
Hamedan
Postal code
Approval date
2013-01-01, 1391/10/12
Ethics committee reference number
349-9-35-16-پ-د

Health conditions studied

1

Description of health condition studied
Insulin-dependent diabetes mellitus
ICD-10 code
E10.9
ICD-10 code description
Insulin-dependent diabetes mellitus.Without complications

Primary outcomes

1

Description
HbA1C
Timepoint
Before and after 2 months of intervention
Method of measurement
IU, ELIZA method

Secondary outcomes

1

Description
Serum Calcium
Timepoint
before and 2 months after intervention
Method of measurement
mg/dl,Chyme Enzyme method

2

Description
Serum Phosphor
Timepoint
before and 2 months after intervention
Method of measurement
mg/dl, Chyme Enzyme method

3

Description
Alkalin phosphatase
Timepoint
before and 2 months after intervention
Method of measurement
U/L, Chyme Enzyme method

Intervention groups

1

Description
Vitamin D3 pearl 50/000 unit every 1 week for 10 weeks manufactured by the Farabi Pharmaceutical
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrine Clinic, Besat Hospital
Full name of responsible person
Zahra Alian
Street address
Endocrine Clinic, Besat Hospital, Motahari Blvd.
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research , School of Medicine, Hamedan University of Medical Sciences
Full name of responsible person
Doctor Heidar Tavilani
Street address
Vice Chancellor for research , School of Medicine, Hamedan University of Medical Sciences
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 , School of Medicine, 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, Hamedan University of Medical Sciences
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 1264 0063
Fax
Email
z_alian@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Medicine, Hamedan University of Medical Sciences
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 1264 0063
Fax
Email
z_alian@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Medicine, Hamedan University of Medical Sciences
Full name of responsible person
Zahra Alian
Position
Assistant
Other areas of specialty/work
Street address
Pediatric Ward2, Besat Hospital, Motahari Blvd.
City
Hamedan
Postal code
Phone
+98 81 1264 0063
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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