This study will be performed in Al-Zahra hospital affiliated to Isfahan University of Medical Sciences. Patients with chronic osteomyelitis who receive linezolid with the dose of 600 mg BID and met the inclusion criteria, will be randomly assigned to two groups of drug and placebo. The patients in drug group will receive oral vitamin B6 with the dose of 40 mg twice daily for 14 days that will be started concurrently with linezolid, while the patients in placebo group will receive placebo tablets with the same dose and duration. Serum level of hemoglobin (Hgb) as well as WBC and platelet count will be recorded before the start of intervention, and at the end of the first, the second, and third weeks of intervention for all patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Manifestation with chronic osteomyelitis
2. Receiving linezolid
Exclusion criteria:
1. Serum level of Hgb less than 8 g/dL
2. White blood cell count less than 4500 cells/mm3
3. Blood platelet count less than 50000 cells/mm3
Intervention groups
Drug group: Vitamin B6 tablet (manufactured by Iran Hormone company), 40 mg orally, twice daily, for 14 days
Placebo group: Placebo tablet (manufactured by Isfahan Faculty of Pharmacy), one tablet orally, twice daily, for 14 days
Main outcome variables
Serum level of hemoglobin, WBC count, platelet count
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150721023282N13
Registration date:2020-08-20, 1399/05/30
Registration timing:registered_while_recruiting
Last update:2020-08-20, 1399/05/30
Update count:0
Registration date
2020-08-20, 1399/05/30
Registrant information
Name
Rasool Soltani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7067
Email address
soltani@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of vitamin B6 compared to placebo on the change of blood cells count in patients with chronic osteomyelitis using linezolid
Public title
Evaluation of the effect of vitamin B6 on blood cells count in patients using linezolid
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Manifestation with chronic osteomyelitis
Use of linezolid
Exclusion criteria:
Serum level of Hgb less than 8 g/dL
WBC count less than 4500 cells/mm3
Platelet count less than 50000 cells/mm3
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method was used in which blocks of 4 were used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drug (vitamin B6) and placebo tablets will be fully similar and packaged in similar containers. The patient, the prescriber (physician), data analyst, and the laboratory personnel will be blind to the content of containers and intervention type.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezar-Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-07-11, 1399/04/21
Ethics committee reference number
IR.MUI.MED.REC.1399.289
Health conditions studied
1
Description of health condition studied
drug-induced pancytopenia
ICD-10 code
D61.811
ICD-10 code description
Other drug-induced pancytopenia
Primary outcomes
1
Description
White blood cell count
Timepoint
Before the intervention, the end of weeks 1, 2, and 3 of intervention
Method of measurement
Flow cytometry
2
Description
Serum level of hemoglobin
Timepoint
Before the intervention, the end of weeks 1, 2, and 3 of intervention
Method of measurement
Flow cytometry
3
Description
Blood platelet count
Timepoint
Before the intervention, the end of weeks 1, 2, and 3 of intervention
Method of measurement
Flow cytometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vitamin B6 tablet (manufactured by Iran Hormone Company), 40 mg, twice daily, for 14 days
Category
Prevention
2
Description
Control group: Placebo tablet (manufactured by Isfahan Faculty of Pharmacy), one tablet, twice daily, for 14 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Kiana Shirani
Street address
Soffeh Ave.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
kianashirani@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Isfahan University of Medical Sciences, Hezar-Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
kianashirani@med.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
50
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
Kiana Shirani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Hezar-Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 7067
Fax
+98 31 3668 0011
Email
kianashirani@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Kiana Shirani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Hezar-Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2086
Fax
Email
kianashirani@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Kiana Shirani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Hezar-Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2086
Fax
Email
kianashirani@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD