Determining the effect of zinc and vitamin C supplement capsules on performance and sexual satisfaction of nulliparous women
Design
A randomized controlled trial clinical trial with parallel, three-blind, randomized groups.
Settings and conduct
This study is performed in gynecological clinics and health centers affiliated with Arak University of Medical Sciences. Samples will be selected from nulliparous women. Then, they are randomly divided into two groups of intervention and control. The intervention group is given capsules containing 10 mg of zinc and 300 mg of vitamin C daily for 4 weeks. The control group is given a capsule containing starch daily as a placebo for 4 weeks. The study is done in three blinds.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to participate in the study, ages 18 to 50, nulliparous women who are 2 weeks after giving birth,Score less than 28 in the Sexual Function Questionnaire. Exclusion criteria: Any disorders caused by pregnancy.
Intervention groups
Group 1 (intervention): Capsules containing 10 mg of zinc and 300 mg of vitamin C are given daily for 4 weeks. Group 2 (placebo): Capsules containing starch are given as a placebo daily for 4 weeks.
Main outcome variables
Sexual performance and satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130731014229N12
Registration date:2021-02-23, 1399/12/05
Registration timing:registered_while_recruiting
Last update:2021-02-23, 1399/12/05
Update count:0
Registration date
2021-02-23, 1399/12/05
Registrant information
Name
Hadi Jafari manesh
Name of organization / entity
Arak University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3503
Email address
jafarimanesh@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-29, 1399/11/10
Expected recruitment end date
2021-09-01, 1400/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of zinc and vitamin C supplementation with placebo on performance and sexual satisfaction of nulliparous women
Public title
The effect of zinc and vitamin C supplementation on sexual function and satisfaction nulliparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
nulliparous women who have passed 2 weeks after giving birth
Age is between 18 and 50 years
Have informed consent to study
Score less than 28 in the sexual function questionnaire.
Exclusion criteria:
Any disorders caused by pregnancy
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are randomly assigned to quadruple blocks A, A, B, B in random groups. So that 20 blocks of 4 letters A and B are made up.Then a block is randomly selected. RAS random allocation software will be used to randomly select blocks. A indicates sample placement in intervention group and B indicates sample placement in control group. First, a block will be randomly identified by RAS software and then the first eligible sample will be entered into the intervention or control group according to the order of the letters A or B. Sampling will continue until all samples are selected.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, principal researcher and data analyzer do not know which groups are located. The samples in the intervention and control group did not know whether they received the placebo or the main drug. The statistician will receive questionnaires as anonymously and in form A and B, and he does not know which are intervention and control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Basij Sq.
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2020-12-13, 1399/09/23
Ethics committee reference number
IR.ARAKMU.REC.1399.279
Health conditions studied
1
Description of health condition studied
Performance and sexual satisfaction of nulliparous women
ICD-10 code
F52.9
ICD-10 code description
Unspecified sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
Women's sexual function score
Timepoint
Before the intervention and four weeks after the intervention
Method of measurement
Women's Sexual Function Questionnaire
2
Description
Women's sexual satisfaction score
Timepoint
Before the intervention and four weeks after the intervention
Method of measurement
Multidimensional scale of women's sexual satisfaction
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Capsules (Omid Health Supplement Company) containing 10 mg of zinc and 300 mg of vitamin C are given daily for 4 weeks.The intervention is performed for patients who have not received any treatment for their problem.
Category
Treatment - Drugs
2
Description
Control group: Capsules containing starch (Niko Shimi Company) are given daily as a placebo for 4 weeks.The intervention is performed for patients who have not received any treatment for their problem.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology Clinic of Arak University of Medical Sciences
Full name of responsible person
Hadi Jafarianesh
Street address
Basij Sq.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
nurse_science@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
n;jv
Street address
Deputy of Research and Technology, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3645
Email
alikamaliir@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafarianesh
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Basij Sq. Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
nurse_science@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafarimanesh
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Basij Sq. Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
nurse_science@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafarimanesh
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Basij Sq. Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
nurse_science@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available