This investigation is a randomized controlled clinical trial to determine the effect of vitamin D supplementation on glucose status, lipid profiles and inflammatory factors in mothers with a history of gestational diabetes. The sample size of study is 44 cases. They are randomly selected according to age and BMI from the list of Yazd Diabetes Research Center. After review of inclusion criteria and obtaining consent, they are assigned to two groups based on random numbers table. Then, up to 10 days after delivery, they are invited to visit Yazd Diabetes Research Center. Women in active arm receive intramuscular injection of vitamin D with 300,000 international units dose and the control group does not receive any complementary. Glucose, insulin, triglyceride, LDL and HDL cholesterol and 25-hydroxy vitamin D and also inflammatory factor that is effective in causing diabetes are measured before and after the time of the follow-up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902113840N1
Registration date:2010-05-21, 1389/02/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-21, 1389/02/31
Registrant information
Name
Mahdieh Hoseinzade Shamsi Anar
Name of organization / entity
Shahid Sadughi University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 35 1624 0691
Email address
hoseinzade.mahdie@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
1. Shahid Sadughi University of Medical Sciences and Health Services 2. Yazd Diabetes Research Center
Expected recruitment start date
2010-01-25, 1388/11/05
Expected recruitment end date
2010-03-01, 1388/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D supplementation on glucose status, lipid profiles and inflammatory factors in mothers with a history of gestational diabetes
Public title
Effect of vitamin D on diabetes prevention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: women with gestational diabetes at their recent pregnancy from the list of GDM Diabetes Research Center of Yazd University, and without thyroid disease, kidney disease, bone disease, PCO, liver disease and not using anti-epilepsy drugs, glucocorticoids, and statins. Exclusion criteria: risk of any illness that requires medication and lack of any willingness to cooperate.
Age
From 20 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
44
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
Shahid Sadughi University of Medical Sciences and Health Services
Street address
Second Centeral Building of Shahid Sadughi University of Medical Sciences and Health Services, Shahid Bahonar square