Comparison of zinc and omega-3 supplementation effect on maternal and fetal outcomes in pregnant women with IUGR fetus with control group, a double-blind placebo controlled clinical trial study
The effect of zinc and omega-3 supplementation in pregnant women with IUGR embryos on maternal and fetal outcomes
Design
Randomized, superiority, parallel group trial design of 117 patients with blinded outcome assessment. Randomization with block randomization method,
Settings and conduct
This double-blind clinical trial study was performed on pregnant women referring to the gynecology and maternity clinic of Sayad Shirazi Hospital, Gorgan, with US based on IUGR embryo and between 28-30 weeks of gestation in 2020.
Participants/Inclusion and exclusion criteria
Pregnant women aged 18-35 years
Pregnant women with a gestational age of more than 20 weeks
Pregnant women with IUGR-based fetal sonography
Maternal body mass index between 15 to 30 kg / m2
No history of allergies to fish and omega 3
Complete information of patients' files
Satisfaction to participate in the study
Intervention groups
The first group will be pregnant mothers who will receive a zinc supplement, the second group will be pregnant mothers who will receive an omega-3 supplement (zinc supplement in the form of tablets containing 30 mg of zinc sulfate produced by Dine Pharmaceutical Company and omega-3 supplement as a Tablets containing EPA eicosopentanoic acid and DHA docosahexaenoic acid produced by Zahravi Pharmaceutical Company
Main outcome variables
neonatal weight ; Apgar score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201130049548N1
Registration date:2020-12-19, 1399/09/29
Registration timing:registered_while_recruiting
Last update:2020-12-19, 1399/09/29
Update count:0
Registration date
2020-12-19, 1399/09/29
Registrant information
Name
Moona Babooie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3226 1150
Email address
dr.babooie@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-15, 1399/08/25
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of zinc and omega-3 supplementation effect on maternal and fetal outcomes in pregnant women with IUGR fetus with control group, a double-blind placebo controlled clinical trial study
Public title
Comparison of zinc and omega-3 supplementation effect on maternal and fetal outcomes in pregnant women with IUGR fetus
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women aged 18-35 years
Pregnant women with a gestational age of more than 20 weeks
Pregnant women with IUGR-based fetal sonography
Maternal body mass index between 15 to 30 kg / m2
No history of allergies to fish and omega 3
Complete patient information
Satisfaction to participate in the study
Exclusion criteria:
Multiple pregnancies
Underlying diseases such as diabetes and high blood pressure
Existence of structural disorders of the uterus
Maternal addiction and smoking
Chronic infection (dehydration, fever)
Chronic liver and kidney disease
placenta previa or decollement
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
117
Randomization (investigator's opinion)
Randomized
Randomization description
We use the block randomization method to randomize subjects into groups that result in equal sample sizes.
We use the block size 6. From the following blocks, first select 1 by accident and divide the samples into three groups according to the order and fill the blocks
A for zinc supplementation and B for omega-3 supplementation and C for placebo
C C B B A A 1
A C C B B A 2
A A C C B B 3
B A A C C B 4
B B A A C C 5
C A A B B C 6
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind and the medical examiner resident , medication provider and patients would not know about the type of treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences, Gorgan,Shastkola road, Philosophical Higher Education Complex
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2020-11-15, 1399/08/25
Ethics committee reference number
IR.GOUMS.REC.1399.280
Health conditions studied
1
Description of health condition studied
neonatal weight
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Apgar score
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Better neonatal weight gain
Timepoint
Neonatal weight at birth time
Method of measurement
Measuring the weight of a newborn baby with a digital scale
2
Description
Apgar score
Timepoint
5th minute Apgar score
Method of measurement
Based on Apgar scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Zinc supplement recipients (zinc supplement in the form of tablets containing 30 mg of zinc sulfate daily for 6 weeks produced by Dineh Pharmaceutical Company)
Category
Prevention
2
Description
Intervention group: Omega-3 supplement recipients (omega-3 supplement in the form of a tablet containing 180 mg EPA eicosopentaanoic acid and 120 mg docosahexaenoic acid DHA at a dose of 120 mg daily for 6 weeks produced by Zahravi Pharmaceutical Company)
Category
Prevention
3
Description
Control group: Placebo recipients (made by Barij Essential Company daily for 6 weeks)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sayyad Shirazi Hospital
Full name of responsible person
Dr Malihe Azadehrah
Street address
Philosophical Higher Education Complex, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
m.azadehrah@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Honarvar
Street address
Philosophical Higher Education, Shast Kola Road, Gorgan
City
GorGan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Email
info@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mona Babooei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
dr.babooie@goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mona Babooei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
dr.babooie@goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mona Babooei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Golestan University of Medical Sciences, Shast Kola Road, Gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3220 2565
Email
dr.babooie@goums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available