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The effect of zinc supplementation on psychological and physical symptoms, sleep quality, quality of life, total antioxidant capacity, serum concentrations of Brain derived neurotrophic factor and high-sensitivity C-reactive protein in young women with premenstrual syndrome

Protocol summary

Study aim
we aim to explore the effects of zinc supplementation PMS patients.
Design
This is a parallel double-blind, randomized, placebo controlled clinical trial.
Settings and conduct
This study has 2 phases. In the first phase young women will be ask to fill the 30 item checklist to temporary diagnosis of the PMS. Women with PMS, will be ask to fill the beck depression and anxiety questionnaires to make sure the are not depressed or have anxiety. In the second phase of study, all the eligible women will record their symptoms with daily record questionnaire for 2 menstrual cycles before the intervention. After 2 cycles, participants who definitely diagnose to have PMS will allocate into 2 groups of 30 subjects, one group will be the intervention and the other group will be the control group. All participants will be assess in a week before menses before and after the intervention. Along with the second package of tablets, subjects will provide with the same daily record questionnaire as before to record their symptoms during next 2 menstrual cycles.
Participants/Inclusion and exclusion criteria
having PMS, age between 18,30, BMI between 18.5-24.9, single healthy young women with regular menstrual cycle of 21-35 days, not being depressed or having anxiety, not taking any oral contraceptives or any medications and zinc supplement in past 3 months, not exercising regularly.
Intervention groups
Intervention group will take zinc gluconate tablets containing 30mg elemental zinc, and control group will take placebo tablets with identical appearance containing starch for 12 weeks.
Main outcome variables
psychological and physical PMS symptoms, sleep quality, quality of life serum levels of BDNF (Brain derived neurotrophic factor), hs-CRP (High-sensitivity C-reactive Protein), TAC ( High-sensitivity C-reactive Protein)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180215038738N1
Registration date: 2018-05-29, 1397/03/08
Registration timing: registered_while_recruiting

Last update: 2018-05-29, 1397/03/08
Update count: 0
Registration date
2018-05-29, 1397/03/08
Registrant information
Name
fatemeh jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3234 4866
Email address
f.jafari@nutr.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of zinc supplementation on psychological and physical symptoms, sleep quality, quality of life, total antioxidant capacity, serum concentrations of Brain derived neurotrophic factor and high-sensitivity C-reactive protein in young women with premenstrual syndrome
Public title
The effect of zinc supplementation on young women with premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18.5 < Body mass index (BMI) < 25 single women regular menstrual cycle of 21-35 days
Exclusion criteria:
taking any medications containing estrogen and progesterone taking zinc supplement in past 3 months exercising regularly being depressed or having anxiety
Age
From 18 years old to 30 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects will be allocating into intervention or placebo group by permuted block randomization method.
Blinding (investigator's opinion)
Double blinded
Blinding description
zinc supplement and placebo will have Identical appearance
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan university of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jirib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2017-06-20, 1396/03/30
Ethics committee reference number
IR.MUI.REC.1396.3.247

Health conditions studied

1

Description of health condition studied
premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome

Primary outcomes

1

Description
physical symptoms of young women with premenstrual syndrome
Timepoint
before and 12 weeks after the start of intervention
Method of measurement
daily record questionnaire

2

Description
psychological symptoms of young women with premenstrual syndrome
Timepoint
before and 12 weeks after the start of intervention
Method of measurement
daily record questionnaire

3

Description
total antioxidant capacity
Timepoint
before and 12 weeks after the start of intervention
Method of measurement
Laboratory analysis ( blood test)

4

Description
serum concentrations of Brain derived neurotrophic factor
Timepoint
before and 12 weeks after the start of intervention
Method of measurement
Laboratory analysis ( blood test)

5

Description
serum concentrations of high-sensitivity C-reactive protein
Timepoint
before and 12 weeks after the start of intervention
Method of measurement
Laboratory analysis ( blood test)

6

Description
serum concentrations of zinc
Timepoint
before and 12 weeks after the start of intervention
Method of measurement
Laboratory analysis ( blood test)

Secondary outcomes

1

Description
sleep quality
Timepoint
before and 12 weeks after the start of intervention
Method of measurement
pittsburgh sleep quality index

2

Description
quality of life
Timepoint
before and 12 weeks after the start of intervention
Method of measurement
World Health Organization Quality Of Life questionnaire

Intervention groups

1

Description
Intervention group: Supplementation of zinc gluconate including 30 mg of elemental zinc (Dine Iran Pharmaceutical Company ),every day 1 supplement, 12 weeks
Category
Treatment - Drugs

2

Description
Control group: placebo (Dine Iran Pharmaceutical Company ), every day 1 supplement, 12 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan University Dormitories
Full name of responsible person
DR. Reza Amani
Street address
Isfahan University and Isfahan University of Medical Sciences dormitories complex, Hezar Jerib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3792 3175
Email
r_amani@mail.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Amirmansour Alavi
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3792 3175
Email
am.alavi@nutr.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Jafari
Position
MSc student of Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food sciences, Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 71 3234 4866
Email
f.jafari.nut@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
DR.Reza Amani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, Hezarjarib sIsfahan University of Medical Sciences, Hezarjarib Street, Isfahantreet, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 31 3792 3175
Email
r_amani@mail.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Jafari
Position
msc student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, Hezarjarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8135798111
Phone
+98 71 3234 4866
Email
f.jafari.nut@gmail.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
Yes - There is 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
Title and more details about the data/document
not decided yet.
When the data will become available and for how long
not decided yet.
To whom data/document is available
not decided yet.
Under which criteria data/document could be used
not decided yet.
From where data/document is obtainable
not decided yet.
What processes are involved for a request to access data/document
not decided yet.
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