1. Home
  2. Approved trials
  3. » فارسی

Evaluation of the effects of vitamin E on the treatment and prevention of relapse in women with lower urinary tract infection

Protocol summary

Study aim
Determination of the effect of vitamin E on the treatment and prevention of relapse in women with lower urinary tract infection
Design
Clinical trial with control group, double-blind, randomized, phase 3 on 80 women with lower urinary tract infection. In this study, individuals will be assigned to intervention and control groups by lottery randomization method.
Settings and conduct
This clinical trial will be performed on 80 women with lower urinary tract infections over 18 years of age referred to the Infectious Clinic of Vali-e-Asr Hospital in Birjand. All of the steps will be covered by the patient, physician and evaluators.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women over 18 years, At least three symptoms including frequency, urgency (urgent need to urinate), dysuria, hematuria, and suprapubic pain Exclusion criteria: History of allergy or intolerance to vitamin E, Peptic ulcer bleeding, Hemophilia, Use of antiplatelet and anticoagulant drugs, Urinary tract obstruction and urological abnormalities, History of renal abscess, Diabetes mellitus, Taking antibiotics in the previous two days, Catheterization two weeks ago, History of hospitalization or catheter in two weeks ago, Kidney stones, Pregnancy and lactation, Immune deficiency (Patients with HIV, etc), Vitamin K deficiency, Liver and renal failure, Candidate for surgery, Flank pain, fever above 37.7 ° C, fever and chills, feeling ill and tired or other evidence of systemic infection, CVA tenderness, symptoms of vaginitis (itching and vaginal discharge)
Intervention groups
Intervention group: Vitamin E softgel 100 units daily for 6 months Control group: Vitamin E softgel placebo 100 units daily for 6 months
Main outcome variables
Frequency, Dysuria, Urgency, Recurrence rate of urinary tract infection, Mean recovery time

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210617051604N1
Registration date: 2021-07-11, 1400/04/20
Registration timing: prospective

Last update: 2021-07-11, 1400/04/20
Update count: 0
Registration date
2021-07-11, 1400/04/20
Registrant information
Name
Razieh Avan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1925
Email address
avanrazieh@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of vitamin E on the treatment and prevention of relapse in women with lower urinary tract infection
Public title
Evaluation of the effect of vitamin E in women with urinary tract infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women over 18 years At least three symptoms including frequency, urgency (urgent need to urinate), dysuria, hematuria, and suprapubic pain
Exclusion criteria:
History of allergy or intolerance to vitamin E Peptic ulcer bleeding Hemophilia Use of antiplatelet and anticoagulant drugs Urinary tract obstruction and urological abnormalities History of renal abscess Diabetes mellitus Taking antibiotics in the previous two days Catheterization two weeks ago History of hospitalization or catheter in two weeks ago Kidney stones Pregnancy and lactation Immune deficiency (Patients with HIV, etc) Vitamin K deficiency Liver and renal failure Candidate for surgery Flank pain, fever above 37.7 ° C, fever and chills, feeling ill and tired or other evidence of systemic infection, CVA tenderness, symptoms of vaginitis (itching and vaginal discharge)
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups using a random number table. First, we create a variable from 1 to 80 in Excel software. Then we create another variable in another column and generate 40 random numbers one and 40 random numbers two with the randomization command. The numbers of one and two are intervention and placebo groups, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
All of the steps will be covered by the patient, physician and evaluators.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2020-09-28, 1399/07/07
Ethics committee reference number
IR.BUMS.REC.1399.303

Health conditions studied

1

Description of health condition studied
Lower urinary tract infection
ICD-10 code
N39.0
ICD-10 code description
Urinary tract infection, site not specified

Primary outcomes

1

Description
Frequency
Timepoint
3 to 5 days after starting treatment
Method of measurement
Questionnaire

2

Description
Dysuria
Timepoint
3 to 5 days after starting treatment
Method of measurement
Questionnaire

3

Description
Urgency
Timepoint
3 to 5 days after starting treatment
Method of measurement
Questionnaire

4

Description
Recurrence rate of urinary tract infection
Timepoint
3 and 6 months after starting treatment
Method of measurement
Questionnaire

5

Description
Mean recovery time
Timepoint
During study
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Vitamin E softgel 100 units daily for 6 months
Category
Treatment - Drugs

2

Description
Control group: Vitamin E softgel placebo 100 units daily for 6 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali-e-Asr Educational and Medical Center affiliated to Birjand University of Medical Sciences
Full name of responsible person
Azadeh Ebrahimzadeh
Street address
Ghaffari Street, Vali-e-Asr Hospital
City
Birjand
Province
South Khorasan
Postal code
9717964151
Phone
+98 56 3162 2001
Email
a.ebrahimzadeh@bums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Deputy of research and technology, Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghaffari Street
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3238 1200
Email
research@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Hajar Mafakher
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Ghaffari Street, Vali-e-Asr Hospital
City
Birjand
Province
South Khorasan
Postal code
9717964151
Phone
+98 56 3162 2001
Email
hajar.mafakher738@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Razieh Avan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Clinical Pharmacy
Street address
Ghaffari Street, Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
avanrazieh@bums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Razieh Avan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Clinical Pharmacy
Street address
Ghaffari Street, Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
avanrazieh@bums.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
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
Loading...