Objective:
- Assumptions:
1 - Administration of folic acid reduces serum Hcy levels in Pregnant women
2 - Administration of folic acid reduces serum lp(a) levels in Pregnant women
3 - Effect of administration of folic acid in reducing Hcy and Lp(a) serum dependent on type of genotype in Methylenetetrahydrofolate reductase polymorphisms
-Objectives :
a) The general purpose design:
Determining effect of administration folic acid in pregnancy on serum homocysteine and LP(a) in Methylenetetrahydrofolate reductase polymorphisms (MTHFR 677C → T)
b) The specific objectives of the project :
1 - Determining effect of administration folic acid on Hcy serum in pregnant women
2 - Determining effect of administration folic acid on Lp (a) serum in pregnant women
3 - Determining effect of administration folic acid in pregnancy on serum homocysteine and LP(a) of pregnant women in different genotypes of Methylenetetrahydrofolate reductase
b) practical objectives:
To clarify the requirement rate of folic acid in pregnant women according to their genotype types to reduce Hcy and Lp (a) serum with purpose of reducing the risk of Pre-eclampsia pregnancy
planning of study:
Interventional-clinical trial
The study population:
Pregnant women
the main criteria for inclusion:
Pregnant women, average age of 20 -30 years
the main criteria for Exclusion:
History of heart disease, chronic hypertension, diabetes mellitus, renal disease, collagen tissue disease, history of preterm labor, abortion, taking calcium and ferrous sulfate, liver disease
sample size: 90 patients
studied intervention or interventions: Administration 5 mg of folic acid
Date of intervention: blood sampling from pregnant women before Administration and 36 weeks of gestation
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014010715903N2
Registration date:2014-05-18, 1393/02/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-18, 1393/02/28
Registrant information
Name
Nadereh Rashtchizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 4666
Email address
rashtchin@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Drug Applied Research Center
Expected recruitment start date
2014-03-01, 1392/12/10
Expected recruitment end date
2015-03-01, 1393/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of prenatal administration of folic acid on serum homocysteine and lipoprotein (a) levels in Methylenetetrahydrofolate reductase polymorphisms
Public title
Effect of prenatal administration of folic acid on serum homocysteine and lipoprotein (a) levels in Methylenetetrahydrofolate reductase polymorphisms
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant wemon with the average age of 20-30 years
Exclusion criteria:
Without history of heart disease; chronic hypertension; diabetes mellitus; renal disease; collagen tissue disease; history of preterm labor; abortion; drug taking calcium and ferrous sulfate; liver disease
Age
From 20 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Drug Applied Research Center
Street address
Department of Biochemistry and Clinical Laboratory, Faculty of Medical science, Tabriz University of Medical science
City
Tabriz
Postal code
Approval date
2013-12-02, 1392/09/11
Ethics committee reference number
7576/4/5
Health conditions studied
1
Description of health condition studied
Pregnant Women
ICD-10 code
O15
ICD-10 code description
Eclampsia
Primary outcomes
1
Description
homocysteine
Timepoint
before Administration and 36 weeks of gestation
Method of measurement
ELISA method using primary and secondary antibodies by ELISA reader
2
Description
lipoprotein (a)
Timepoint
before Administration and 36 weeks of gestation
Method of measurement
Nephlometric Method by Autoanalyzer
Secondary outcomes
1
Description
LDH
Timepoint
before Administration and 36 weeks of gestation
Method of measurement
Autoanalyzer
2
Description
Urea
Timepoint
before Administration and 36 weeks of gestation
Method of measurement
Autoanalyzer
3
Description
Creatinine
Timepoint
before Administration and 36 weeks of gestation
Method of measurement
Autoanalyzer
4
Description
Platelet
Timepoint
before Administration and 36 weeks of gestation
Method of measurement
Cell counter
5
Description
Urinary creatinine
Timepoint
before Administration and 36 weeks of gestation
Method of measurement
Autoanalyzer
Intervention groups
1
Description
After Administration of folic acid for all the Pregnant women at the dose of 5 mg For 36 week,
blood sampling from all the pregnant women Participations before Administration and after 36 weeks of gestation will be taken
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Drug Applied Research Center, Tabriz University of medical Sciences
Full name of responsible person
Dr.Nadereh Rashtchizadeh
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Drug Applied Research Center
Full name of responsible person
Dr. Nadereh Rashtchizadeh
Street address
Department of Biochemistry and Clinical Laboratory, Faculty of Medical science, Tabriz University of Medical science
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Drug Applied Research Center
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
Drug Applied Research Center
Full name of responsible person
Dr. Nadereh Rashtchizadeh
Position
PHD of clinical biochemistry/Faculty member
Other areas of specialty/work
Street address
Department of Biochemistry and Clinical Laboratory, Faculty of Medical science, Tabriz University of Medical science
City
Tabriz
Postal code
Phone
+98 914 114 5493
Fax
Email
rashtchizadeh@roketmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Drug Applied Research Center
Full name of responsible person
Dr. Nadereh Rashtchizadeh
Position
PHD of clinical biochemistry/Faculty member
Other areas of specialty/work
Street address
Department of Biochemistry and Clinical Laboratory, Faculty of Medical science, Tabriz University of Medical science
City
Tabriz
Postal code
Phone
00
Fax
Email
rashtchizadeh@roketmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Drug Applied Research Center
Full name of responsible person
Dr. Nadereh Rashtchizadeh
Position
PHD of clinical biochemistry/Faculty member
Other areas of specialty/work
Street address
Department of Biochemistry and Clinical Laboratory, Faculty of Medical science, Tabriz University of Medical science
City
Tabriz
Postal code
Phone
00
Fax
Email
rashtchizadeh@roketmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)