Evaluation of the difference between two protocols of iron deficiency anemia in diabetic type II patients; given ferrous sulfate on consecutive versus alternate day
Rising hemoglobin quantity and ferritin for iron deficiency anemia in diabetic
Design
Clinical trial intervention group,one blind,2 phase , random allocation
Settings and conduct
Measuring the amount of hemoglobin and ferritin for50 diabetics who have iron deficiency anemia in one blind study that participants didn't know they were in which group of study.
Participants/Inclusion and exclusion criteria
Entry requirements: Hemoglobin level 9 to 12 and 9 to 13, in order women and men,exclusion criteria: transfusion or iron infusion
Intervention groups
intervention group used 2 tablets every other days in morning
Evaluation of the difference between two protocols of iron deficiency anemia in diabetic type II patients; given ferrous sulfate on consecutive versus alternate day
Public title
Treatment of anemia in diabetic type II patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hemoglobin level 9 to 12 and 9 to 13, in order women and men
Needless to transfusion or iron infusion
The patient has just iron deficiency anemia
A1C hemoglobin level is less than 9.
Exclusion criteria:
Patients who do not sign the ethical consent form.
Patients who do not cooperate during the treatment for any reason.
Patients who are moved from oral diabetes treatment to injection for any reason during anemia treatment
Severe liver failure
History of gastric surgery
Diabetic patients who have different type of anemia
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
100
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method; Restricted Randomization in the form of permuted block randomization
randomization unit; Replacement block amount of six
How to build a sequence;Sequence allocation software can produce both blocks and Sequence
Allocation concealment; Central Randomization: Randomized sequences are only at the disposal of the project manager, and after entering the study, the participants are randomly assigned to each of the groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are defined with A, B codes in the study, where the outcome analyst does not know what type of treatment is included in each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Esfand street Farvardin blvd golestan town
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2019-03-08, 1397/12/17
Ethics committee reference number
ir.ajums.rec.1397.924
Health conditions studied
1
Description of health condition studied
Iron deficiency anemia
ICD-10 code
D50
ICD-10 code description
Iron deficiency anemia
Primary outcomes
1
Description
Analysing the difference of Iron sulphate each day and every 2 days between those patients who are suffering from diabetes and are have low blood iron.
Timepoint
8weeks for group A 16weeksfor group B
Method of measurement
hemoglobin quantity
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: given FeSo4 on alternate day
Category
Treatment - Drugs
2
Description
Control group: given FeSo4 on consecutive
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Bahareh Taati
Street address
Esfand st
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3221 8617
Email
info@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Badavi
Street address
Esfand st
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3221 8617
Fax
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ahvaz university of medical science
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
Ahvaz University of Medical Sciences
Full name of responsible person
Bahareh taati
Position
Pharmacy student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Esfand st
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3221 8617
Email
bahareh_taati@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Reza Ganji
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Esfand st
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3221 8617
Email
rgpharm777@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Bahareh Taati
Position
pharmacy student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Esfand st
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
009832218617
Email
bahareh_taati@yahoo.com
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