The effect of zinc supplementation on satisfaction, sexual function and testosterone levels in postmenopausal women
Design
The study is a clinical trial performed 116 people and two intervention and control groups
Settings and conduct
The study was conducted on population referred to the Menopause clinic of Imam Khomeini hospital in Ahvaz Menopause ; these patents were first evaluated by FSFI and Larson questionnaire and voluntarily entered the study. Subjects were given a diet for six weeks Post-test was completed after six weeks
Participants/Inclusion and exclusion criteria
Married, literate, 49 years of age, post menopausal, FSFI less than 26.5 and Larson less than 50 and on plasma less than 62 and People who did not have entry criteria excuded
Intervention groups
Two groups of intervention and control group intake Zink supplementation 110 mg for six weeks in the intervention and placebo in the control group
Main outcome variables
Postmenopausal Sexual Function and Satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191007045010N1
Registration date:2019-11-27, 1398/09/06
Registration timing:registered_while_recruiting
Last update:2019-11-27, 1398/09/06
Update count:0
Registration date
2019-11-27, 1398/09/06
Registrant information
Name
Leila Mazaherinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5536 1002
Email address
mazaherinia.l@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-07, 1398/07/15
Expected recruitment end date
2020-01-05, 1398/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Zinc supplementation on sexual satisfaction, sexual function and testosterone level in postmenopausal women
Public title
The effect of Zinc supplementation on sexual satisfaction, sexual function and testosterone level in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women
At least one year and a maximum of 5 years since the last menstrual period
Minimum literacy
49 years and up
People whose FSFI score is <26.5
Those who achieved according ton Larsson questionnaire of sexual dissatisfaction (score of 50 and below), low sexual satisfaction (score of 51-75)
People whose fasting plasma zinc is less than 62 micrograms / dL
Exclusion criteria:
Having at least one known chronic illness
Current experience of mental disorders and depression in the sample of the researcher and his wife
Addiction, alcohol abuse and smoking
Drugs affecting sexual function
Those who use replacement hormones
Age
From 49 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the research sample and the experimenter do not know which sample (control or intervention) the sample is in.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Medical Sciences Ethics Committee
Street address
No.6/415، Nine Bahar steet، Abadan
City
Ahwaz
Province
Khouzestan
Postal code
6315733653
Approval date
2019-09-28, 1398/07/06
Ethics committee reference number
IR. AJUMS. REC. 1398. 466
Health conditions studied
1
Description of health condition studied
Postmenopausal Sexual Disorders
ICD-10 code
F66
ICD-10 code description
Other sexual disorders
Primary outcomes
1
Description
Sexual Function: A set of sexual responses and reactions including sexual desire, satisfaction, vaginal lubrication, orgasm and pain in sexual intercourse with the spouse, which is determined by the Sexual Function Index Questionnaire with a FSFI score greater than or equal to 26.5 Desirable Sexual Function and FSFI score less than 26.5 is considered sexual dysfunction and people with FSFI score less than 26.5 are included in the study
Timepoint
Day zero and 43
Method of measurement
FSFI questionnaire
2
Description
Sexual satisfaction: means the objective feelings of satisfaction, satisfaction, and enjoyment experienced by a spouse when considering all aspects of their marriage. Persons who, according to the Larsson Questionnaire of Sexual dissatisfaction (score 50 and below), low sexual satisfaction (score51-75) they enter the study
Timepoint
Day zero and 43
Method of measurement
Larson questionnaire
Secondary outcomes
1
Description
Testosterone levels
Timepoint
Before the study and day 43
Method of measurement
The radioimmunoassay method
Intervention groups
1
Description
Intervention group:intake of Zink Sulfate capsule 110 mg Alhavi Pharmaceutical Company daily for 42 days
Category
Treatment - Drugs
2
Description
Control group:Intake placebo daily for 42 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Mina Irvani
Street address
No.6/415، Nine Bahar steet، Abadan
City
Ahwaz
Province
Khouzestan
Postal code
6315733653
Phone
Fax
Email
Leylimzn@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Muhammad Bedoui
Street address
Golestan
City
Ahwaz
Province
Khouzestan
Postal code
6315733653
Phone
Email
badvi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Leila Mazaheri nia
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.6/415، Nine Bahar steet، Abadan
City
Ahwaz
Province
Khouzestan
Postal code
6315733653
Phone
+98 61 5332 9401
Email
Leylimzn@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mina Irvani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
No.6/415، Nine Bahar steet، Abadan
City
Ahwaz
Province
Khouzestan
Postal code
6315733653
Phone
+98 61 5332 9401
Email
Minairavani2004@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Leila Mazaherinia
Position
MA.Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 9، West Bahar Ave: Row 415 6 Room: Abadan town
City
Abadan
Province
Khouzestan
Postal code
6315733653
Phone
+98 61 5536 1002
Fax
Email
mazaherinia.l@ajums.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available