Objectives:
To evaluate the effect of high dose and low dose of folic acid on the levels of soluble receptor activator of nuclear factor – kappa B ligand / Osteoprotegerin ratio during the first trimester of pregnancy.
Specific objectives
1- Determining effect of administration of folic acid at high dose (5mg/day until delivery) on serum RANKL/OPG ratio in pregnant women.
2- Determining effect of administration of folic acid at low dose (0.5mg/day until delivery) on serum RANKL/OPG ratio in pregnant women.
3- Determining effect of administration of folic acid at low dose (0.5mg/day until delivery) on serum TNFα levels in pregnant women.
4- Determining effect of administration of folic acid at high dose (5mg/day until delivery) on serum TNFα levels in pregnant women.
Practical objectives: To clarify the requirement rate of folic acid in pregnant women to reduce RANKL/OPG ratio and TNFα levels with purpose of reducing the risk of Pre-eclampsia pregnancy
Inclusion criteria: Pregnant women, average age of 20 -30 years
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: in single blind randomized clinical trial 88 patients in two similar groups will receive daily from early pregnant until delivery 5 mg/day in group 1 and 0.5 mg/day in group 2. The incidence of hypertension and the laboratory change in the levels of RANKL/OPG ratio and TNFα levels will compare between two study groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013122315903N1
Registration date:2014-07-08, 1393/04/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-08, 1393/04/17
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, Tabriz University of Medical Sciences
Expected recruitment start date
2014-03-03, 1392/12/12
Expected recruitment end date
2015-03-03, 1393/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison study on the effect of prenatal administation of high dose and low dose folic acid on surem RANKL/OPG ratio in pregnancy
Public title
Comparison study on the effect of prenatal administation of high dose and low dose folic acid on surem RANKL/OPG ratio in pregnancy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Pregnant women with mean of 30-20 years
Exclusion Criteria: Hstory of heart disease; chronic hypertension;diabetes mellitus;renal disease; collagen tissue disease; history of preterm labor; abortion; taking calcium and ferrous sulfate; liver disease
Age
From 20 years old to 30 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of medical sciences
Street address
Tabriz University of medical sciences- Tabriz -Iran
City
Tabriz
Postal code
Approval date
2014-02-12, 1392/11/23
Ethics committee reference number
5/4/11671
Health conditions studied
1
Description of health condition studied
pregnant women
ICD-10 code
O15
ICD-10 code description
Eclampsia
Primary outcomes
1
Description
Osteoprotegerin
Timepoint
Before intervention and 36th week of pregnancy
Method of measurement
ELISA Kit
2
Description
RANKL
Timepoint
Before intervention and 36th week of pregnancy
Method of measurement
ELISA Kit
3
Description
TNFα
Timepoint
Before intervention and 36th week of pregnancy
Method of measurement
ELISA Kit
Secondary outcomes
1
Description
Calcium
Timepoint
Before intervention and 36th week of pregnancy
Method of measurement
auto analyzer& Compared with control
2
Description
Phosphorus
Timepoint
Before intervention and 36th week of pregnancy
Method of measurement
auto analyzer& Compared with control
3
Description
Alkaline phosphatase
Timepoint
Before intervention and 36th week of pregnancy
Method of measurement
auto analyzer& Compared with control
Intervention groups
1
Description
High dose group: 44 pregnant women will receive folic acid 5 mg daily from early pregnancy until delivery.
Category
Prevention
2
Description
Low dose group: 44 pregnant women will receive folic acid 0.5 mg daily from early pregnancy until delivery.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaykol raeis Clinic
Full name of responsible person
Dr.Nadereh Rashtchizadeh
Street address
Tabriz Universite of Medical Sciences, Shaykholraeis Cilinic
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Drug Applied Research Center, Tabriz University of Medical Sciences- Tabriz- iran
Full name of responsible person
Dr.nadereh rashtchizadeh
Street address
Department of Clinical Biochemistry and Laboratory Medicine,Medical Faculty, Tabriz University of Medical Sciences
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, Tabriz University of Medical Sciences- Tabriz- iran
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, Tabriz University of Medical Sciences
Full name of responsible person
Dr.nadereh rashtchizadeh
Position
phd of clinical biochemistry/Professor
Other areas of specialty/work
Street address
Department of Clinical Biochemistry and Laboratory Medicine,Medical Faculty, Tabriz University of Medical Sciences