Evaluation of the effect of high dose vitamin D3 supplementation on improvement of bacterial vaginosis in women with vitamin D deficiency
Design
Parallel group, open label, randomized, phase 3 controlled trial of 40 patients
Settings and conduct
This study is an open label clinical trial that will be done in a Gynecology clinic in ُShahid Motahari hospital. Patients will be randomly assigned to the vitamin D3 or control group. Outcomes will be assessed at the initiation of the study and 14 days after completion of treatment.
Participants/Inclusion and exclusion criteria
Premenopausal women aged> 16 years with serum 25 (OH) D concentration of < 20 ng / ml and bacterial vaginosis will be included. Women with any of the following conditions will be excluded: concurrent vaginal candidiasis or trichomoniasis, being in the bleeding phase of menstruation, systemic or vaginal use of antibiotics in the past 2 weeks, pregnancy and lactation.
Intervention groups
Intervention group: Patients will receive metronidazole tablet 500 mg twice daily for one week. Moreover, patients will receive a 50000 IU soft gel capsule of vitamin D per day for 5 days.
Control group: participants will only receive metronidazole tablet 500 mg twice daily for one week.
Main outcome variables
Number of clinical outcome responders, defined as patients with normal vaginal discharge, vaginal secretions pH < 4.5, negative whiff test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150609022637N7
Registration date:2020-06-20, 1399/03/31
Registration timing:registered_while_recruiting
Last update:2020-06-20, 1399/03/31
Update count:0
Registration date
2020-06-20, 1399/03/31
Registrant information
Name
Naemeh Nikvarz
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5017
Email address
nnikvarz@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-28, 1399/02/09
Expected recruitment end date
2020-07-21, 1399/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of high dose vitamin D3 on improvement of bacterial vaginosis in vitamin D deficient women
Public title
Study of the effect of vitamin D3 on improvement of bacterial vaginosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premenopausal women aged> 16 years
Serum 25 (OH) D concentration of < 20 ng / ml
Having bacterial vaginosis
Exclusion criteria:
Concurrent vaginal candidiasis or trichomoniasis
Being in the bleeding phase of menstruation
Systemic or vaginal use of antibiotics in the past 2 weeks
Pregnancy
Lactation
Age
From 16 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization with randomly selected block sizes of 4,6 and 8. For example a block size of 4 randomizes 4 participants, and each participant is assigned to one of the intervention groups based on the arranged series of intervention groups in this block.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Research assistance office of Kerman University of Medical Sciences, Ebne-Sina street
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2020-04-27, 1399/02/08
Ethics committee reference number
IR.KMU.REC.1399.102
Health conditions studied
1
Description of health condition studied
Bacterial vaginosis
ICD-10 code
N76.0
ICD-10 code description
Acute vaginitis
Primary outcomes
1
Description
Number of patients respond clinically defined as those with normal vaginal discharge, vaginal secretion pH < 4.5, and negative whiff test
Timepoint
At baseline and 14 days after completion of treatment
Method of measurement
Self reported characteristics of vaginal discharge including odor and color of discharge, measurement of pH of vaginal secretion with pH strips, for performing the whiff test, several drops of 10% potassium hydroxide is added to the sample of vaginal discharge. Release of a fish amine odor indicates a positive whiff test.
Secondary outcomes
1
Description
Percentage of clue cells on microscopic examination of the vaginal wet mount
Timepoint
At baseline and 14 days after completion of the study
Method of measurement
Microscopic examination of vaginal discharge
2
Description
Serum concentration of 25 (OH) vitamin D
Timepoint
At baseline and end of the study
Method of measurement
Laboratory tests in hospital laboratory
Intervention groups
1
Description
Intervention group: Patients will receive metronidazole tablet 500 mg twice daily for one week. Moreover, patients will receive a 50000 IU soft gel capsule of vitamin D per day for 5 days.
Category
Treatment - Drugs
2
Description
Control group: participants will only receive metronidazole tablet 500 mg twice daily for one week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahary hospital
Full name of responsible person
Sima Mousavi
Street address
Kashani street
City
Urmia
Province
West Azarbaijan
Postal code
5714615463
Phone
+98 44 3222 7002
Email
sima.mosavi65@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Office of the Vice Chancellor for Research, Ebne-sina Ave., Jahad Blvd.
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
kmu_research@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Naemeh Nikvarz
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Clinical pharmacy
Street address
Faculty of pharmacy, Kerman Unuversity of Medical Sciences, Haft bagh boulevard
City
Kerman
Province
Kerman
Postal code
7616911319
Phone
+98 34 3132 5017
Fax
+98 34 3132 5003
Email
nnikvarz@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Naemeh Nikvarz
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Clinical pharmacy
Street address
Faculty of pharmacy, Kerman Unuversity of Medical Sciences, Haft bagh boulevard
City
Kerman
Province
Kerman
Postal code
7616911319
Phone
+98 34 3132 5017
Fax
+98 34 3132 5003
Email
nnikvarz@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Naemeh Nikvarz
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Clinical pharmact
Street address
Faculty of pharmacy, Kerman Unuversity of Medical Sciences, Haft bagh boulevard
City
Kerman
Province
Kerman
Postal code
7616911319
Phone
+98 34 3132 5017
Fax
+98 34 3132 5003
Email
nnikvarz@kmu.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