Objective: The aim of this study is to determine the effects of calcium and vitamin D co-supplementation on insulin resistance, inflammatory factor and biomarkers of oxidative stress in gestational diabetes. Study design: Double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks' gestation will be included in this study. The use of substitute treatments including hormone or vitamin supplements as well as those with preeclampsia, complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study. Population and sample size: 60 patients with GDM among pregnant women of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either calcium and vitamin D supplements (intervention group) or placebo (control group). Fasting blood samples will be taken at baseline and after 6-wk intervention to measure metabolic profiles, inflammatory factor and biomarkers of oxidative stress. Start and End Date of Intervention: 2 months (November 20, 2013-Janvier 20, 2014). Outcomes: Baseline and End-of-trial fasting plasma glucose (FPG), serum insulin, hs-CRP levels, plasma total antioxidant capacity (TAC) and total glutathione (GSH).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311205623N11
Registration date:2013-12-01, 1392/09/10
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2013-12-01, 1392/09/10
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2013-11-20, 1392/08/29
Expected recruitment end date
2014-01-19, 1392/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of calcium and vitamin D co-supplementation on insulin resistance and inflammatory factors in women with gestational diabetes
Public title
Effect of calcium and vitamin D in treatment of gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Pregnant women aged 18-40 years; diagnosed with GDM at 24-28 weeks' gestation.
Exclusion Criteria: The use of substitute treatments including hormone or vitamin supplements; patients with preeclampsia; complete bed rest (CBR); intra uterine fetal death (IUFD); placenta abruption; preterm delivery.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Postal code
Approval date
2013-11-20, 1392/08/29
Ethics committee reference number
3460/1/5/29/P
Health conditions studied
1
Description of health condition studied
Gestational diabetes mellitus
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
Description
Fasting plasma glucose
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
2
Description
Insulin
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
3
Description
Hs-CRP
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
4
Description
Total Antioxidant Capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vitamin D3 capsule, 50000 IU, every 3 weeks for 6 weeks orally.
Intervention group: Calcium tablet, 500 mg, two times a day for 6 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule, every 3 weeks for 6 weeks orally.
Control group: Placebo tablet, two times a day for 6 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutrition PhD
Other areas of specialty/work
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Postal code
Phone
+98 36 1446 3378
Fax
Email
asemi_z@kaums.ac.irasemi_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Zatollah Asemi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)