The Comparison of hemoglobin and hematocrit in two groups receiving vitamin B6 and iron with iron in women with iron deficiency anemia referred to health and medical centers of Gonabad city in 1398
Determination of hemoglobin and hematocrit in the two groups receiving vitamin B6 and iron with iron in women with iron deficiency anemia
Design
The present study will be a clinical trial with two equal arms of samples selected first by the simple method of non-pregnant women with iron deficiency anemia referring to health centers of Gonabad city with ferritin level less than 12 micrograms per liter, and to evaluate vitamin B efficacy;66 women The randomized block allocation method will be divided into intervention and control groups.
Settings and conduct
Women with iron deficiency anemia will have informed consent if they have inclusion criteria and desire to participate in the study and will be divided into intervention and control groups. Complete blood counts will be performed again after one month. To check the complete blood cell count, all women will receive 2 cc of blood in an EDTA vacuum tube and will be tested with the BC5800 CBC manufacturing in 2015.
Participants/Inclusion and exclusion criteria
MCV <80fl, MCH <27pg, MCHC <33g / dl, ferritin <12mcg / l and HB = 8-12gr /
Exclusion criteria:
cut or change medication، Not willing to participate in the study
Intervention groups
Intervention group will be given 100 mg iron tablets daily (ferrous sulfate) and 80 mg vitamin B6 tablet (pyridoxine hydrochloride manufactured by Iran Hormone Company) and control group will receive 100 mg iron.
Main outcome variables
By determining the effect of vitamin B6 on CBC, it can be used in the treatment of anemia to achieve a shorter and less costly treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190730044382N1
Registration date:2019-08-27, 1398/06/05
Registration timing:retrospective
Last update:2019-08-27, 1398/06/05
Update count:0
Registration date
2019-08-27, 1398/06/05
Registrant information
Name
Asma Salar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5728 8961
Email address
salar.a.stu@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-04, 1398/05/13
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of hemoglobin and hematocrit in two groups receiving vitamin B6 and iron with iron in women with iron deficiency anemia referred to health and medical centers of Gonabad city in 1398
Public title
The effect of vitamin B6 on anemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
MCV <80fl and MCH <and MCHC <33g /dl and ferritin <12mcg / l HB = 8-12gr / dl
No history of gastrointestinal bleeding and gastrointestinal surgery and diseases associated with malabsorption including celiac based on patient statement and records
No drug and hemoglobin-increasing agents in the last month (blood transfusion, intravenous administration of iron, iron tablets and erythropoietin in the last one month)
Lack of any hereditary anemia (including thalassemia and tuberculosis anemia ... based on patient's statement)
Lack of chronic disease based on history
Not taking other medicines (based on patient's statement or accompanying medication)
Not taking supplements, including multivitamins and calcium, on a patient statement
No smoking
No alcohol or coffee utilization
No pregnant
Exclusion criteria:
cutt or change medication
Not taking iron tablets in the control group and the case even once
Not taking vitamin B6 in the case group for even one time
Not willing to participate in the study further
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Santo Road Asian Margin
City
Gonabad
Province
Razavi Khorasan
Postal code
5643312237
Approval date
2019-07-27, 1398/05/05
Ethics committee reference number
IR.GMU.REC.1398.071
Health conditions studied
1
Description of health condition studied
Iron deficiency anemia
ICD-10 code
D50.9
ICD-10 code description
Iron deficiency anemia, unspecified
Primary outcomes
1
Description
Percentage of people with increased hemoglobin
Timepoint
At baseline and 30 days after intervention
Method of measurement
To check the complete blood cell count, all women will receive 2 cc of blood in an EDTA vacuum tube and will be tested with the BC5800 CBC manufacturing in 2015.
2
Description
Percentage of people with increased hematocrit
Timepoint
At baseline and 30 days after intervention
Method of measurement
To check the complete blood cell count, all women will receive 2 cc of blood in an EDTA vacuum tube and will be tested with the BC5800 CBC manufacturing in 2015.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will be given 100 mg iron tablets daily (ferrous sulfate) and 80 mg vitamin B6 tablets (pyridoxine hydrochloride manufactured by Iran Hormone Company) for one month.
Category
Treatment - Drugs
2
Description
Control group: 100 mg iron tablets (ferrous sulfate) daily will be given for one month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bohlol Hospital
Full name of responsible person
Farhang Soltanee
Street address
Saadi Street, Vahdat Boulevard,
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5723 6833
Email
Research@gmu.ac.ir
2
Recruitment center
Name of recruitment center
Fayyaz Bakhsh Health Center
Full name of responsible person
Asma Salar
Street address
Ghadir Square, next to the Blood Transfusion Center,Gonabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5722 2598
Email
Research@gmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Shahla Khosravan
Street address
Gonabad University of Medical Sciences adjutancy Education and Research, Asian Road Margin
City
Gonabad
Province
Razavi Khorasan
Postal code
9691797852
Phone
+98 51 5722 3814
Email
Research@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Asma Salar
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.7, Gaem Ave, Gonabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
9691145435
Phone
+98 51 5728 8961
Fax
Email
salar.a.stu@gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Asma Salar
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.7, Gaem Ave, Gonabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
9691145435
Phone
+98 51 5728 8961
Fax
Email
salar.a.stu@gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Asma Salar
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.7, Gaem Ave, Gonabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
9691145435
Phone
+98 51 5728 8961
Fax
Email
salar.a.stu@gmu.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
No - There is not 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