The goal of this study is determining the efficiency of therapeutic dose of vitamin D in preventing occurrence of gestational Diabetes Mellitus.
The main including criteria are :
1) Patient desire
2) Gestational age below 16 weeks
3) No history of diabetes mellitus type 2 or gestational Diabetes Mellitus
4) No family history of Diabetes Mellitus type 1 in first degree relatives
5) Obesity
The main excluding criteria are:
1) Patient dissatisfaction and discontinuation of follow up
2) incorrect consumption of vitamin D
The study was performed on three groups of 75 pregnant women referring to obstetric clinic of Shahid Beheshti and Alzahra hospital in Esfahan city in 2012 (overall 225 persons)
At first, the level of serum vitamin D is measured between 14 to 16 weeks of gestation. Persons with level of below 10 nmol per liter are divided to groups A and B, randomly. Group A are treated with vitamin D supplementation with dose of 50000 unit every two weeks for ten weeks. Group B are not treated with vitamin D supplementation.
Among persons with level of above 25 nmol per liter, 75 persons were selected as normal healthy control group.
At the end of the study between 24 to 26 weeks of gestation the oral glucose tolerance test was performed in groups A and B (as consumption of 75 gram oral glucose and measurement of blood glucose level 1 and 2 hours later).
First hour post-prandial glucose level more than 180 mg per dl and second hour level more than 155 mg per dl or FBS above 95 are considered as impaired glucose tolerance test.
Also these two groups are compared with normal control group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201309277513N4
Registration date:2014-01-03, 1392/10/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-03, 1392/10/13
Registrant information
Name
Hatav Ghasemi Tehrani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 113 4081
Email address
tehrani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of effectiveness of Vitamin D supplementation in decreasing the development of the gestational diabetes mellitus in pregnant women
Public title
comparison of effectiveness of Vitamin D supplementation in decreasing the development of the gestational diabetes mellitus in in pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Including Criteria
patient satisfaction; normal BMI; gestational age below 16w,s; no history of diabetes mellitus type 2 or gestational diabetes mellitus ; no family history of Diabetes Mellitus type 1 in first degree relatives.
Excluding Criteria
patient dissatisfaction; Incorrect Consumption of Vitamin D Supplementation; Follow up discontinuation
Gestational age 14 to 16 weeks: serum Vitamin D level / 24 to 26 weeks: Serum blood sugar level and glucose tolerance test
Method of measurement
Based on laboratory test for vitamin D and blood sugar level
Secondary outcomes
empty
Intervention groups
1
Description
The study was performed on three groups of 75 pregnant women referring to obstetric clinic of Shahid Beheshti and Alzahra hospital in Esfahan city in 2012 (overall 225 persons)
At first, the level of serum vitamin D is measured between 14 to 16 weeks of gestation. Persons with level of below 10 nmol per liter are divided to groups A and B, randomly. Group A are treated with vitamin D supplementation with dose of 50000 unit every two weeks for ten weeks. Group B are not treated with vitamin D supplementation.
Among persons with level of above 25 nmol per liter, 75 persons were selected as normal healthy control group.
At the end of the study between 24 to 26 weeks of gestation the oral glucose tolerance test was performed in groups A and B (as consumption of 75 gram oral glucose and measurement of blood glucose level 1 and 2 hours later).
First hour post-prandial glucose level more than 180 mg per dl and second hour level more than 155 mg per dl or FBS above 95 are considered as impaired glucose tolerance test.
Also these two groups are compared with normal control group.
Category
Prevention
2
Description
Control group
Pregnant women with 14 to 16 weeks of gestational age with serum vitamin D level above 25 nmol/liter
Category
Prevention
3
Description
Study groups
1- Pregnant women with gestational age of 14 to 16 weeks with serum vitamin D level below 10 nmol per liter without vitamin D supplementation
2- Pregnant women with gestational age of 14 to 16 weeks with serum vitamin D level below 10 nmol per liter treated with vitamin D supplementation as 50000 unit dosage every 2 weeks for 10 weeks
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan,Shahid Beheshti hospital and Alzahra Hospital
Full name of responsible person
Behnaz Banihashemi
Street address
Num 7 Parastoo building,Between south Resalat and Farabi ave, Sheikh Koleini st, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Dr. Hatav Ghasemi Tehrani
Street address
Isfahan- Alzahra Hospital- Gynecology Department
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University Of Medical Sciences
Full name of responsible person
Dr. Hatav Ghasemi Tehrani
Position
Assistant Professor
Other areas of specialty/work
Street address
Isfahan- Alzahra Hospital- Gynecology Group
City
Isfahan
Postal code
Phone
+98 913 406 9069
Fax
Email
tehrani@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
Dr. Hatav Ghasemi Tehrani
Position
Assistant Professor
Other areas of specialty/work
Street address
Isfahan- Alzahra Hospital- Gynecology Department
City
Isfahan
Postal code
Phone
+98 31 1624 9032
Fax
Email
tehrani@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University Of Medical Sciences
Full name of responsible person
DR. Behnaz Banihashemi
Position
Gynecology Resident
Other areas of specialty/work
Street address
Isfahan - Alzahra Hospital - Gynecology Department
City
Isfahan
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)