Determining the effect of folic acid supplementation and the active form of folate on homocysteine levels in postmenopausal women with metabolic syndrome.
Determination of the interventional effect of daily folic acid administration on total homocysteine before and after the intervention.
Determining the interventional effect of daily administration of the active form of folate on total homocysteine before and after the intervention.
Reduction of homocysteine through administration of active folate formulation with a safe dose in postmenopausal women in order to improve the risk factors of cardiovascular diseases.
Design
The clinical trial has 2 intervention groups, with parallel groups, double-blind, randomized, block randomization method with 4 blocks is used for randomization.
Settings and conduct
The study will be conducted in Baharlu Hospital, Tehran. In this study, the participant, the clinical caregiver and the researcher will not know about the type of intervention and the study is double-blind. Blinding is done by block randomization method with blocks of 4.The first group receives 1 mg of active folate daily for 4 months and the second group received 1 mg of folic acid daily for 4 months.
Participants/Inclusion and exclusion criteria
Females aged 53 to 70 years who have passed menopause for at least 2 years and have metabolic syndrome
Intervention groups
The first group receives 1 mg of active folate daily for 4 months.
The second group received 1 mg of folic acid daily for 4 months.
Investigating the effect of the active form of folate compared to folic acid on homocysteine level inpostmenopausal women with metabolic syndrome
Public title
Investigating the effect of the active form of fulate on homocysteine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female gender
Age between 53 to 70
At least 2 years have passed since menopause
Having criteria for metabolic syndrome
Exclusion criteria:
History of miocardial infarction
Drinking alcohol or smoking
Age
From 53 years old to 70 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Individual simple randomization with block randomization method in blocks of four
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants, the clinical caregiver and the researcher will not know about the type of intervention and the supplements will be completely similar in shape and size
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences
Street address
North Kargar Ave., Boy's College of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1439955975
Approval date
2024-07-13, 1403/04/23
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.166
Health conditions studied
1
Description of health condition studied
Metabolic syndrome, hyperhomocysteinemia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Serum homocysteine level
Timepoint
Measurement of serum homocysteine level before the intervention and 4 months after taking the drug
Method of measurement
Blood biochemistry test
Secondary outcomes
1
Description
Cholesterol
Timepoint
Cholesterol level measurement before the intervention and 4 months after the intervention
Method of measurement
blood test
2
Description
High-density lipoprotein
Timepoint
Measurement before the intervention and 4 months after the intervention
Method of measurement
blood test
3
Description
Low-density lipoprotein
Timepoint
Measurement before the intervention and 4 months after the intervention
Method of measurement
blood test
4
Description
triglyceride
Timepoint
Measurement before the intervention and 4 months after the intervention
Method of measurement
blood test
Intervention groups
1
Description
First intervention group: 1 mg of the active form of folate daily for 4 months
Category
Treatment - Drugs
2
Description
Second intervention group: 1 mg of folic acid daily for 4 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baharloo hospital
Full name of responsible person
mohammad abed
Street address
North Kargar Ave., Boy's College of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 936 284 5781
Email
M-Abed@student.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
معاونت تحقیقات و فناوری دانشگاه علوم پزشکی تهران
Street address
Pour Sina St
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 21 81631
Email
tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Abed
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
Gynecology and Obstetrics
Street address
North Kargar Ave., Boy's College of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 936 284 5781
Fax
Email
M-Abed@student.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Abed
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
Gynecology and Obstetrics
Street address
North Kargar Ave., Boy's College of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 936 284 5781
Fax
Email
M-Abed@student.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Abed
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
Gynecology and Obstetrics
Street address
North Kargar Ave., Boy's College of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1439955975
Phone
+98 936 284 5781
Fax
Email
M-Abed@student.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main and secondary outcomes that have been investigated
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions and people working in industry
Under which criteria data/document could be used
If the data is used to conduct further studies in this field
From where data/document is obtainable
Mohammad Abed by phone number 00989362845781 or email M-Abed@student.tums.ac.ir
What processes are involved for a request to access data/document
If the conditions are met, the information will be given to the applicant within 1 month at most