The objective of this randomized, not blinded trial is to investigate the effect of different doses of vit D on the insulin resistance in pregnant women. In this study, 90 pregnant women who meet the inclusion/exclusion criteria will be recruited and randomly assigned into two interventions or control group. The pregnant women in the intervention groups will receive 2000 or 4000 IU vit D daily for 6 months while in the control group will receive 200 IU (conventional dose) vit D, daily for 6 months. Fasting blood sugar, 25 hidroxy vit D, insulin and homeostatic model assessment (HOMA) will be measured before and after the intervention and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811203312N1
Registration date:2011-05-23, 1390/03/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-05-23, 1390/03/02
Registrant information
Name
Sedigheh Soheilykhah
Name of organization / entity
Yazd Diabetes Research Center, Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1522 3999
Email address
s_soheilykhah@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Diabetes Research Center, Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2010-03-06, 1388/12/15
Expected recruitment end date
2011-09-06, 1390/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of different doses of vitamin D on insulin resistance in pregnant women attending in Shahid Sadoughi and Mojibian prenatal clinics
Public title
Effect of different doses of vitamin D on insulin resistance in pregnant women attending in Shahid Sadoughi and Mojibian prenatal clinics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women with gestational age less than 12 weeks without gestational diabetes, history of PCO, BMI less than 27kg/m2 before pregnancy, no Vit D supplementation in the past 6 months
Exclusion criteria: diabetes or gestational diabetes treated with insulin, thyroid or parathyroid disorders, hypertension, polycystic ovary (PCO) s
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd Diabetes Research Center, Shahid Sadoughi University of Medical Sciences
Street address
Afshar Alley, Jomhuri BLV. , Yazd, Iran
City
Yazd
Postal code
8917965556
Approval date
2010-08-08, 1389/05/17
Ethics committee reference number
48204/17/پ
Health conditions studied
1
Description of health condition studied
Gestational Diabetes
ICD-10 code
O24
ICD-10 code description
Diabetes mellitus in pregnancy
Primary outcomes
1
Description
Insulin
Timepoint
Before intervention and 6 months after intervention
Method of measurement
Insulin kit
2
Description
Vitamin D
Timepoint
Before intervention and 6 months after intervention
Method of measurement
Vit D kit
3
Description
FBS
Timepoint
Before intervention and 6 months after intervention
Method of measurement
Auto Analyser method
4
Description
Insulin resistance Index
Timepoint
Before intervention and 6 months after intervention
Method of measurement
Measuring of HOMA index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Vit D supplementation, 2000 IU, daily for 6 months
Category
Treatment - Drugs
2
Description
Control group: vit D, 200 IU (conventional dose), daily for 6 months
Category
Treatment - Drugs
3
Description
Intervention group2: Vit D supplementation, 4000 IU, daily for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi and Mojibian prenatal clinics in Yazd
Full name of responsible person
Dr. Sedigheh Soheilykhah
Street address
Shahid Sadoughi hospital, Yazd, Iran
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd Diabetes Research Center, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Sedigheh Soheilykhah
Street address
Afshar Alley, Jomhuri BLV. , Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd Diabetes Research Center, Shahid Sadoughi 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
Yazd Diabetes Research Center, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Sedigheh Soheilykhah
Position
Assistant professor of internal medicine
Other areas of specialty/work
Street address
Afshar Alley, Jomhuri BLV. , Yazd, Iran
City
Yazd
Postal code
8917965556
Phone
+98 35 1522 3999
Fax
+98 35 1525 8354
Email
s_soheilykhah@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Diabetes Research Center, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Sedigheh Soheilykhah
Position
Assistant professor of internal medicine
Other areas of specialty/work
Street address
Afshar Alley, Jomhuri BLV. , Yazd, Iran
City
Yazd
Postal code
8917965556
Phone
+98 35 1522 3999
Fax
+98 35 1525 8354
Email
S_Soheilykhah@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Diabetes Research Center, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Sedigheh Soheilykhah
Position
Assistant professor of internal medicine
Other areas of specialty/work
Street address
Afshar Alley, Jomhuri BLV. , Yazd, Iran
City
Yazd
Postal code
8917965556
Phone
+98 35 1522 3999
Fax
+98 35 1525 8354
Email
S_Soheilykhah@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)