The purpose of this study is practical and affordable and accessible solution for optimal control of diabetes and finally reducing diabetes complications.
We studied patients with type I diabetes who are referred to Taleghani Hospital.These patients are about sixty people who will be invited by call and The demographic characteristics will be recorded through the questionnaires.Then sent to the laboratory. their HbA1C ،25OHD،Ca ،Mg, PTH،P and Alk-p will be checked.those with Vitamin D deficiency and insufficiency will be enrolled.Each of these individuals have been treated with vitamin D and Calcium for about twelve weeks.Then again, HbA1C and 25OHD are measured at 12th week.HbA1C levels will be compared before and after vitamin D consumption in patients with vitamin D deficiency and insufficiency.The results are analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013070113822N1
Registration date:2013-08-23, 1392/06/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-23, 1392/06/01
Registrant information
Name
Sakineh Mohammadian
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1222 7720
Email address
mohammadian@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
public - Golestan University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of vitamin D supplementation on HbA1C in patients with type I diabetes mellitus and vitamin D deficiency
Public title
Evaluation the effect of vitamin D supplementation in patients with type I diabetes mellitus and vitamin D deficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: type I diabetic and vitamin D deficiency patients; normal liver function; normal renal function.
exclusion criteria:Irregular use of calcium and vitamin D during the study; hypercalciuria with nephrolithiasis .
Age
To 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences,Shast Kola Road, Gorgan, Golestan
City
Gorgan
Postal code
Approval date
2012-10-31, 1391/08/10
Ethics committee reference number
19108102111
Health conditions studied
1
Description of health condition studied
diabetes (mellitus):type I
ICD-10 code
E10
ICD-10 code description
diabetes (mellitus):type I
2
Description of health condition studied
Vitamin D deficiency, unspecified
ICD-10 code
E55.9
ICD-10 code description
Vitamin D deficiency, unspecified
Primary outcomes
1
Description
25OHD
Timepoint
before intervention,three mounths after intervention
Method of measurement
blood sampling, ng/dl
2
Description
HbA1C
Timepoint
before intervention,three mounths after intervention
Method of measurement
blood sampling
Secondary outcomes
1
Description
mg
Timepoint
before intervention
Method of measurement
blood sampling,Mg/dl
2
Description
p
Timepoint
before intervention
Method of measurement
bleeding sample/ Mg/dl
3
Description
pth
Timepoint
before intervention
Method of measurement
ng/l
4
Description
ca
Timepoint
before intervention
Method of measurement
blood sampling,Mg/dl
Intervention groups
1
Description
for all patients with vitamin D deficiency,single dose of vitamin D(300,000 unit) will be injected intra muscular.Non-cooperative patients treated weekly with pearl vitamin D (50,000unit) orally for eight weeks.
for avoiding Hungry Bone, syrup calcium(40 Mg/Kg/Day) will be consumed for about three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani children hospital
Full name of responsible person
Dr. Sakineh Mohammadian, pediatrician,associated professor
Street address
Taleghani children hospital, Janbazan Blv., Gorgan
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Dr. Mohamad Jafar Golalipoor
Street address
Golestan University of Medical Sciences,Research and Technology Department, Shastkola Road
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan 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
Golestan university of Medical Science
Full name of responsible person
Dr. Nasrin Fatahi
Position
resident, project executer
Other areas of specialty/work
Street address
Taleghani hospital, Janbazan Blv.r, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1222 7720
Fax
Email
nfty3063@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neonatal and Children Health Research Center, Golestan University of Medical Science
Full name of responsible person
Dr. Sakineh Mohammadian, pediatrician, associated professor
Position
pediatrician, associated professor
Other areas of specialty/work
Street address
Talghani Hospital, Janbazan Blv., Gorgan
City
Gorgan
Postal code
Phone
+98 17 1222 7720
Fax
Email
saminmoh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Dr. Nasrin Fatahi
Position
Resident, project executor
Other areas of specialty/work
Street address
Talghani Hospital, Janbazan Blv, Gorgan
City
Gorgan
Postal code
Phone
+98 17 1222 7720
Fax
Email
nfty3063@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)