Objective: The aim of this study is to determine the effects of vitamin D plus calcium co-supplementation on pregnancy outcomes in gestational diabetes. Study design: parallel 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 pre-eclampsia, complete bed rest (CBR), intra uterine fetal death (IUFD), placenta abruption and preterm delivery will be excluded in the study. Population and sample size: 50 patients with GDM among pregnant women of eligible and referred to Kossar Clinic affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected. Intervention: Patients will be assigned to receive either vitamin D plus calcium supplements (intervention group: n=25) or placebo (control group: n=25). Fasting blood samples will be taken at baseline and after 6-wk intervention to measure serum vitamin D and calcium levels. Although the intervention will be done for 6 weeks, all participants will be followed until delivery. Start and End Date of Intervention: 5 months (March 10, 2014-August 10, 2014). Outcomes: Baseline and End-of-trial fasting plasma glucose (FPG), serum vitamin D and calcium levels. Polyhydramnios will be diagnosed with sonographic estimation method at post-intervention. Infants' weight, length, head circumference, 5-min Apgar score and ponderal index will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201407115623N23
Registration date:2014-07-21, 1393/04/30
Registration timing:retrospective
Last update:
Update count:1
Registration date
2014-07-21, 1393/04/30
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
Arak University of Medical Sciences
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D plus calcium co-supplementation on pregnancy outcomes in gestational diabetes
Public title
Effect of supplementation 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:
50
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
Arak University of Medical Sciences
Street address
Vice-chancellor for Education and Research, Sardasht Avenue, Arak
City
Arak
Postal code
Approval date
2014-02-03, 1392/11/14
Ethics committee reference number
92-158-19
Health conditions studied
1
Description of health condition studied
Gestational diabetes
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
Description
Newborn's head circumference
Timepoint
Delivery time
Method of measurement
Tape
2
Description
Newborn's weight
Timepoint
Delivery time
Method of measurement
Scale
3
Description
Ponderal index
Timepoint
Delivery time
Method of measurement
Calculation
4
Description
Polyhydramnios
Timepoint
End-of-trial
Method of measurement
Sonographic
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vitamin D3 capsule, 50000 IU, every 3 weeks for 6 weeks orally.
Category
Treatment - Drugs
2
Description
Intervention group: Calcium tablet, 500 mg, two times a day for 6 weeks orally.
Category
Treatment - Drugs
3
Description
Control group: Placebo capsule, every 3 weeks for 6 weeks orally.
Category
Treatment - Drugs
4
Description
Control group: Placebo tablet, two times a day for 6 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kossar Clinic
Full name of responsible person
Maryam Karamali
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Maryam Karamali
Street address
Vice-chancellor for Education and Research, Sardasht Avenue, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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 Science
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 31 5546 3378
Fax
Email
asemi_z@kaums.ac.irasemi_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Science
Full name of responsible person
Zatollah Asemi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.irasemi_r@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)