The Impact of Vitamin D Supplementation in Gestational Diabetes Cases on Post-Partum Glucose Tolerance and Insulin Resistance: A Randomized Controlled Trial
Study goal:determining the effect of vitamin D deficiency treatment during pregnancy on post partum glucose tolerance test. study design:randomized , with control. inclusion criteria:gestattional diabetes, singleton pregnancies , vitamin D deficient women older than 16 who filled the patient's informed consent. exclusion criteria: women who does not eat take vitamin D pearls and does not fill the informed consent. sample size:110 interventions: taking 14 pearls of 50000 IU vitammin D intervention time: 12- 32 weeks of pregnancy. first outcome: Decrease rate of DM, IFG anf IGT at 6-12 weeks after delivery
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012101611144N1
Registration date:2012-10-24, 1391/08/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-10-24, 1391/08/03
Registrant information
Name
Dr. Majid Valizadeh
Name of organization / entity
Zanjan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 24 1727 0714
Email address
valizadeh@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2012-10-23, 1391/08/02
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of Vitamin D Supplementation in Gestational Diabetes Cases on Post-Partum Glucose Tolerance and Insulin Resistance: A Randomized Controlled Trial
Public title
Gestational diabetes and vitamin D
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: gestattional diabetes, singleton pregnancies , vitamin D deficient women older than 16 who filled the patient's informed consent.
Exclusion criteria:
1- women with overt diabetes.
2- fat malabsorbtion
3- vitamin D injection or taking vitamin D pearls with high dose( 6 or more pearls of 50000 IU viamin D) in last 3 months.
4- hypothyroidism or hyperthyroidism
5- hypertension.
6- unwiliingness to fill the testiomonial.
7- not using the pearls
Age
From 16 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
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
Zanjan University of Medical Sciences
Street address
Zanjan,Azadi Boulevard,Zanjan university of Medical Science
City
Zanjan
Postal code
Approval date
2012-10-13, 1391/07/22
Ethics committee reference number
A-11-45-7
Health conditions studied
1
Description of health condition studied
Gestational diabetes
ICD-10 code
O24.4
ICD-10 code description
Diabetes mellitus arising in pregnancy
Primary outcomes
1
Description
Glucose tolerance test
Timepoint
6-12 weeks after delivery
Method of measurement
blood glucose level
Secondary outcomes
1
Description
Insulin resistance
Timepoint
6-12 weeks after delivery
Method of measurement
HOMA-IR calculation
Intervention groups
1
Description
Control group: blood glucose, vitamin D and Ca measurement.
Category
N/A
2
Description
vitamin D, pearl 50000 IU, at first taking 4 pearls in 2days following(2 for each day) and then weekly. In the cases more than 30 weeks, weekly 2 pearls
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Education and treatment center of Valieasr
Full name of responsible person
Street address
City
Zanjan
2
Recruitment center
Name of recruitment center
Education and treatment center of Musavi
Full name of responsible person
Street address
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Alireza Biglari
Street address
Zanjan University of Medical Science,Azadi boulvard, Zanjan
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?