The current study is a controlled randomised clinical trial, is done on pregnant women who referred to the Shahid Mostafa Khomeini hospital, the only Obstetrics and Gynecology training centre in Ilam city, in 2014. 30 patients were assigned to each group. Inclusion criteria include women with at least one of the risk factors for preeclampsia; in the second half of pregnancy. Exclusion criteria included lack of cooperation; intake of multi mineral and vitamin in the control group. The first group receives one tablet multi minerals (Claci-care that contained 800 mg calcium, 200mg magnesium and 8mg zinc) per day, 2. The second group receives 250 mg vitamin C and 55mg vitamin E (one tablet vitamin E and 2 tablets vitamins C per day) 3. The third group was the control group who only receives ferrous sulfate (which is only for pregnant women). After obtaining informed consent and explaining the purpose and importance of the study, the experiment began. The risk factors of preeclampsia will be determined by a specialist. The patients from 20 weeks to 28 weeks of gestation monthly, from weeks 28 to 36 on a fortnightly and then weekly basis until the delivery were visited in Mostafa Khomeini’s Hospital for blood pressure and in the Laboratory of Imam Khomeini’s Hospital for their proteinuria. Furthermore, 24 hours after giving birth, They will be examined for signs of disease.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016062528617N1
Registration date:2016-09-24, 1395/07/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-24, 1395/07/03
Registrant information
Name
Milad Azami
Name of organization / entity
Ilam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 938 031 6334
Email address
miladazami@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Ilam University of Medical Sciences
Expected recruitment start date
2015-03-16, 1393/12/25
Expected recruitment end date
2016-03-05, 1394/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Multi Minerals (Zn, Mg and Ca) and Vitamins (C and E) Supplementation in the Prevention of Preeclampsia
Public title
The effects of Multi Minerals (Zn, Mg and Ca) and Vitamins (C and E) Supplementation in the Prevention of Preeclampsia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria included women with at least one of the risk factors for preeclampsia (including chronic vascular disease, multiple pregnancy, history of preeclampsia at or near the previous pregnancy, history of thrombophilia or APA syndrome, high maternal age, obesity, etc.); in the second half of pregnancy (20 weeks gestation or later). Exclusion criteria included lack of cooperation; intake of multi mineral and vitamin in the control group.
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ilam University of Medical Sciences
Street address
Faculty of Medicine, Ilam University of Medical Sciences, Pazhohesh Boulevard, Ilam
City
Ilam
Postal code
6939177143
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
EC/93/H/223
Health conditions studied
1
Description of health condition studied
Preeclampsia
ICD-10 code
O14
ICD-10 code description
O14.9
Primary outcomes
1
Description
The incidence of preeclampsia
Timepoint
The patients from 20 weeks to 28 weeks of gestation monthly, from weeks 28 to 36 on a fortnightly and then weekly basis until the delivery were visited in Mostafa Khomeini’s Hospital for blood pressure and in the Laboratory of Imam Khomeini’s Hospital for their proteinuria
Method of measurement
Preeclampsia is described with the signs such as the minimum standards hypertension after 20 weeks of pregnancy and proteinuria of ≥300 mg per 24 hours or equal to +1 in urine dipstick
Secondary outcomes
empty
Intervention groups
1
Description
The first group receives one tablet multi minerals (Claci-care that contained 800 mg calcium, 200mg magnesium and 8mg zinc) per day. Follow up: The patients from 20 weeks to 28 weeks of gestation monthly, from weeks 28 to 36 on a fortnightly and then weekly basis until the delivery.
Category
Treatment - Drugs
2
Description
The second group receives 250 mg vitamin C and 55 mg vitamin E. Follow up: The patients from 20 weeks to 28 weeks of gestation monthly, from weeks 28 to 36 on a fortnightly and then weekly basis until the delivery.
Category
Treatment - Drugs
3
Description
The third group was the control group who only receives ferrous sulfate (which is only for pregnant women). Follow up: The patients from 20 weeks to 28 weeks of gestation monthly, from weeks 28 to 36 on a fortnightly and then weekly basis until the delivery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mostafa Khomeini hospital
Full name of responsible person
Milad Azami
Street address
Faculty of Medicine, Ilam University of Medical Sciences, Pazhohesh Boulevard, Ilam
City
Ilam
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Milad Azami
Street address
Faculty of Medicine, Ilam University of Medical Sciences, Pazhohesh Boulevard, Ilam
City
Ilam
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Student Research Committee, Ilam University of Medical Sciences, Ilam, Iran
Full name of responsible person
Milad Azami
Position
Medical Student
Other areas of specialty/work
Street address
Faculty of Medicine, Ilam University of Medical Sciences, Pazhohesh Boulevard, Ilam
City
Ilam
Postal code
6939177143
Phone
+98 938 031 6334
Fax
Email
milad98azami@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Medicine,
Full name of responsible person
Khadijeh Pourtaghi
Position
General Physician
Other areas of specialty/work
Street address
Faculty of Medicine, Ilam University of Medical Sciences, Pazhohesh Boulevard, Ilam
City
Ilam
Postal code
6939177143
Phone
+91 87217728
Fax
Email
kh.pourtaghi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Student Research Committee
Full name of responsible person
Milad Azami
Position
Medical student
Other areas of specialty/work
Street address
Faculty of Medicine, Ilam University of Medical Sciences, Pazhohesh Boulevard, Ilam
City
Ilam
Postal code
6939177143
Phone
+98 938 031 6334
Fax
Email
milad98azami@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)