A total of 140 postmenopausal women aged between 48 to 58 years old are randomly assigned to two groups of 70 subjects; group 1 receive traditional HRT with calcium + vitamin D tablet and group 2 receive only calcium + vitamin D tablet. The cognitive function of the women are considered by MOCA questionnaire before and after 6 months and are compare between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604043743N2
Registration date:2016-07-12, 1395/04/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-12, 1395/04/22
Registrant information
Name
Saeideh Ziaei
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3555
Email address
ziaei_sa@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University.Jalal Al Ahmad street Tehran Iran
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of HRT on cognitive function in postmenopausal women
Public title
The effects of HRT on cognitive function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: natural menopause; maximum 10 years from menopause, without any contraindication for hormone therapy; no HRT in previous 6 months; without any chronic disease such as cancer psychological diseases; no addiction or smoking; no hyperplasia or myoma in the uterus.
Age
From 48 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tarbiat Modares University
Street address
Tarbiat Modares University, Jalal Al Ahmad street
City
Tehran
Postal code
14115315
Approval date
2013-12-11, 1392/09/20
Ethics committee reference number
52/5000
Health conditions studied
1
Description of health condition studied
Cognitive dysfunction
ICD-10 code
F06.7
ICD-10 code description
Mild cognitive disorder
Primary outcomes
1
Description
Cognitive function
Timepoint
After 6 months
Method of measurement
MOCA questionnaire
Secondary outcomes
1
Description
Climacteric symptom
Timepoint
After 6 months
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group 1: HRT and calcium +D tablet (0.625 mg cojugated estrogen plus 2.5 mg medroxy progestron +calcium D 500 mg + 200 Iu vitamin D) daily for six months
Category
Treatment - Drugs
2
Description
Intervention group 2: Calcium +vitamin D tablet (500mg calcium+200 Iu vitamin D) daily for six months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat 1, 2 clinics
Full name of responsible person
Street address
City
Kerman
2
Recruitment center
Name of recruitment center
Dr. Ziaei Clinic
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr. Movaheddin
Street address
Tarbiat Modares University, Jalal Al Ahmad St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Saeideh Ziaei
Position
Professor
Other areas of specialty/work
Street address
Tarbiat Modares University, Jalal Al Ahmad street
City
Tehran
Postal code
39
Phone
+98 21 8288 3555
Fax
+98 82883585
Email
ziaei_sa@modares.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Saeideh Ziaei
Position
Professor
Other areas of specialty/work
Street address
Tarbiat Modares University, Jalal Al Ahmad street
City
Tehran
Postal code
Phone
+98 21 8288 3555
Fax
Email
ziaei_sa@modares.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares Univrersity
Full name of responsible person
Saeideh Ziaei
Position
Prof
Other areas of specialty/work
Street address
Jalal al ahmad street
City
tehran
Postal code
14115111
Phone
+98 21 8288 3555
Fax
+98 21 8288 4560
Email
ziaei_sa@modares.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)