Effects of calcium and vitamin D co-supplementation on pre-elampsia parameters, metabolic status and biomarkers of oxidative stress in pregnant women at risk for pre-eclampsia
Objective: This study is to determine the effects of vitamin D on metabolic profiles, hs-CRP and biomarkers of oxidative stress in pregnant women at risk for pre-eclampsia. Study design: Randomized double-blind controlled clinical trial. Inclusion and Exclusion Criteria: Pregnant women, primigravida, aged 18-40 year old at 20 weeks' gestation with positive screening tests will be included in this study. Multiparous women as well as those with hypertension, gestational diabetes mellitus (GDM), 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 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 50000 IU vitamin D/each 2 weeks and 1000 mg calcium daily (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12-wk intervention to measure metabolic profiles and biomarkers of oxidative stress. Start and End Date of Intervention: 12 weeks (September 7, 2014- December 7, 2014).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102135444N3
Registration date:2015-01-31, 1393/11/11
Registration timing:retrospective
Last update:
Update count:1
Registration date
2015-01-31, 1393/11/11
Registrant information
Name
Mansoore Samimi
Name of organization / entity
Kashan
Country
Iran (Islamic Republic of)
Phone
+98 36 1446 0180
Email address
samimi_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2014-05-06, 1393/02/16
Expected recruitment end date
2014-09-07, 1393/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of calcium and vitamin D co-supplementation on pre-elampsia parameters, metabolic status and biomarkers of oxidative stress in pregnant women at risk for pre-eclampsia
Public title
Effect of supplementation in treatment of pregnancy complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Pregnant women; primigravida; aged 18-40 years old who were carrying singleton pregnancy at 20 weeks' gestation; positive screening tests. Exclusion Criteria: Multiparous women; patients with hypertension; gestational diabetes mellitus (GDM); 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
2
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
Ethics Committee of Kashan University of Medical Sciences
Street address
Ravandi Ghotbe Blvd
City
Kashan
Postal code
Approval date
2014-03-31, 1393/01/11
Ethics committee reference number
196/1/5/29/پ
Health conditions studied
1
Description of health condition studied
Pre-eclampcy
ICD-10 code
O94
ICD-10 code description
Sequelae of complication of pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Total cholesterol
Timepoint
Baseline and 12 weeks after the intervention
Method of measurement
Enzymatic
2
Description
LDL-cholesterol
Timepoint
Baseline and 12 weeks after the intervention
Method of measurement
Enzymatic
3
Description
Triglycerides
Timepoint
Baseline and 12 weeks after the intervention
Method of measurement
Enzymatic
4
Description
HDL-cholesterol
Timepoint
Baseline and 12 weeks after the intervention
Method of measurement
Enzymatic
5
Description
Fasting plasma glucose
Timepoint
Baseline and 12 weeks after the intervention
Method of measurement
Enzymatic
6
Description
Plasma total antioxidant capacity
Timepoint
Baseline and 12 weeks after the intervention
Method of measurement
Spectrophotometry
7
Description
Total glutathione
Timepoint
Baseline and 12 weeks after the intervention
Method of measurement
spectrophotometry
8
Description
Serum insulin levels
Timepoint
Baseline and 12 weeks after the intervention
Method of measurement
Eliza
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 50000 IU vitamin D pearl, each two weeks for 12 weeks + 1000 mg calcium tablet, daily for 12 weeks
Category
Treatment - Drugs
2
Description
Control group: Vitamin D Placebo pearl, each two weeks for 12 weeks + Calcium Placebo tablet, daily for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Dr Mansooreh Samimi
Street address
Naghavi Hospital
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Dr Gholamali Hamidi
Street address
Vice chancellor for research, Ghotbe Ravandi Blvd
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Mansooreh Samimi
Position
Obstetricians
Other areas of specialty/work
Street address
Beheshti Hospital
City
Kashan
Postal code
Phone
+98 31 5544 7619
Fax
Email
samimi_m@kaums.ac.ir; dr_samimi.2007@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Mansooreh Samimi
Position
Obstetricians
Other areas of specialty/work
Street address
Beheshti Hospital
City
Kashan
Postal code
Phone
+98 31 5544 7619
Fax
Email
samimi_m@kaums.ac.ir; dr_samimi.2007@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Mansooreh Samimi
Position
Obstetricians
Other areas of specialty/work
Street address
Beheshti Hospital
City
Kashan
Postal code
Phone
+98 31 5544 7619
Fax
Email
samimi_m@kaums.ac.ir; dr_samimi.2007@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)