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 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 50000 IU vitamin D/each 2 weeks (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 (July 23, 2014- October 23, 2014). Outcomes: Baseline and End-of-trial serum total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides levels, fasting plasma glucose (FPG), plasma total antioxidant capacity (TAC) and total glutathione (GSH).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410035623N27
Registration date:2014-10-04, 1393/07/12
Registration timing:retrospective
Last update:
Update count:1
Registration date
2014-10-04, 1393/07/12
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
2014-06-22, 1393/04/01
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of vitamin D supplementation on metabolic profiles in pregnant women who are at risk of 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 year old who were carrying singleton pregnancy at 27 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
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
Arak University of Medical Sciences
Street address
Vice-chancellor for Education and Research, Sardasht Avenue, Arak
City
Arak
Postal code
Approval date
2013-08-26, 1392/06/04
Ethics committee reference number
92/151/2
Health conditions studied
1
Description of health condition studied
Pregnancy
ICD-10 code
O94
ICD-10 code description
Sequelae of complication of pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Insulin
Timepoint
Baseline and End-of-trial
Method of measurement
Eliza
2
Description
Nitric oxide
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
3
Description
hs-CRP
Timepoint
Baseline and End-of-trial
Method of measurement
Eliza
4
Description
Total antioxidant capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
5
Description
Fasting plasma glucose
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
6
Description
Triglyceride
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
7
Description
Cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
8
Description
HDL-cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vitamin D pearl, 50000 IU, each two weeks for 12 weeks
Category
Treatment - Drugs
2
Description
Control group: Placebo pearl, each two weeks for 12 weeks
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)