Comparison of the effectiveness of iron deficiency anemia treatment with daily protocol and one day in between with oral iron
Design
This study is a phase 3 parallel randomized clinical trial. Individuals are told that they are randomly assigned to one of these two groups of 188people.
Settings and conduct
one group of patients are treated daily and in the second group every other day with oral iron. One week after the start of treatment, changes in the patient's clinical symptoms, at the time of diagnosis and 1.5 months after the start of treatment, the parameters are checked.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age ≥ 15 years and less than 50 years
Women with iron deficiency with ferritin less than 30 micrograms per liter
No pregnancy and breastfeeding
Absence of comorbidities (ckd, DM, IHD, etc.)
No history of inflammatory bowel disease and celiac diseas,thalassemia,inherited bleeding disorder
Do not take multivitamin and mineral supplements (35 mg or more of essential iron per day) in the 2 weeks prior to randomization
No allergy to oral iron
Lack of intravenous iron therapy in the last 12 weeks
Not receiving anticoagulant therapy
No surgery and chemotherapy for the next 12 weeks.
Lack of creatinine clearance less than 30 ml per minute and hemoglobin less than 80 g / l with active bleeding
Lack of hypermenorrhea
Exclusion criteria:
Intolerance or non-response to oral iron gluconate, sulfate or fumarate in the last 12 weeks
Received frequent anemia treatments and are resistant to anemia treatment.
Dissatisfaction to participate in the study or lack of cooperation and consent to continue treatment
Intervention groups
one group of patients will receive 150-200 mg of elemental iron daily and the second group of patients will receive 150- 200 mg of elemental iron every other day
Main outcome variables
Hb, clinical signs, side effects, retic count, TIBC
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210730052015N1
Registration date:2021-09-25, 1400/07/03
Registration timing:registered_while_recruiting
Last update:2021-09-25, 1400/07/03
Update count:0
Registration date
2021-09-25, 1400/07/03
Registrant information
Name
Negar Gheytassi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3147 3521
Email address
drnegar.gheytassi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-21, 1400/06/30
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of treatment of iron deficiency anemia with daily vs. every other day oral iron supplementation
Public title
Comparison of the effectiveness of treatment of iron deficiency anemia with daily vs. every other day oral iron supplementation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age ≥ 15 years and less than 50 years
outpatients Women with iron deficiency with ferritin less than 30 micrograms per liter
No pregnancy
No breastfeeding right now
Absence of comorbidities (ckd, DM, IHD, etc.)
Lack of known history of inflammatory bowel disease
Lack of known history of celiac disease
No known history or thalassemia
No known hereditary bleeding disorder
Do not take multivitamin and mineral supplements (35 mg or more of essential iron per day) in the 2 weeks prior to randomization.
No allergy to oral iron
Lack of intravenous iron therapy in the last 12 weeks
Do not receive anticoagulants (eg warfarin, apixaban, debigatran, adoxaban, Riveroxban)
Lack of creatinine clearance less than 30 ml per minute
Lack of hemoglobin less than 80 g / l with active bleeding
No chemotherapy planned for the next 12 weeks.
No surgery is scheduled for the next 12 weeks.
Exclusion criteria:
Intolerance or non-response to oral iron gluconate, sulfate or fumarate in the last 12 weeks
Received frequent anemia treatments and are resistant to anemia treatment.
Dissatisfaction to participate in the study or lack of cooperation and consent to continue treatment
Age
From 15 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
376
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomized block method was used for randomization. For this purpose, a block of 4 is used. In such a way that first 4 blocks are prepared as BAAB, BABA, BBAA, AABB, ABAB, ABB and then these blocks are arranged randomly and people are assigned to two groups according to A or B and this work is continuous. Will be repeated to reach the desired sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is one-sided blind, which means that none of the participants is aware of how individuals are assigned to the groups. Labels A and B are labeled on the packages, but only the researcher knows the true nature of the supplements.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
University of Medical Sciences, Payambar Azam University Complex. Deputy of research and technology
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2021-06-27, 1400/04/06
Ethics committee reference number
IR.ARAKMU.REC.1400.074
Health conditions studied
1
Description of health condition studied
Iron deficiency anemia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
hemoglobin
Timepoint
The beginning of the study, two weeks and a month and a half after the intervention
Method of measurement
Using the device
2
Description
Ferritin
Timepoint
At the beginning of the study and one and a half months after the intervention
Method of measurement
Using the device
3
Description
Retic COUNT
Timepoint
First and two weeks after the intervention
Method of measurement
Using the device
4
Description
Serum iron levels
Timepoint
At the beginning of the study and one and a half months after the intervention
Method of measurement
Using the device
5
Description
TIBC
Timepoint
At the beginning of the study and one and a half months after the intervention
Method of measurement
Using the device
Secondary outcomes
1
Description
General clinical symptoms(weakness, fatigue, drowsiness, restlessness, anxiety, etc.)
Timepoint
at the beginning and end of the study
Method of measurement
check list
2
Description
Side effects during the study (nausea and vomiting, black stools / heartburn, etc.)
Timepoint
during the study
Method of measurement
check list
Intervention groups
1
Description
Intervention group: In one group of patients, 150-200 mg of elemental iron is given daily (in the form of ferrofort tablets of Abidi Pharmaceutical Company twice a day).
Category
Treatment - Drugs
2
Description
Intervention group: In the second group, patients are treated every other daybetween 150-200 mg of elemental iron (in the form of ferrufort tablets of Abidi company twice a day every other day).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
درمانگاه تخصصی بیمارستان امیرالمومنیت اراک
Full name of responsible person
Negar Gheytassi
Street address
اراک، میدان بسیج (سردشت)، جنب دانشکده پزشکی، بیمارستان امیرالمومنین
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
Drnegar.gheytassi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
علیرضا کمالی
Street address
Finance Management, Third Floor, Arak University of Medical Sciences, Alma Al-Huda St., Shahid Shiroodi St.
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3312 4955
Email
dopdarman@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Negar Gheytassi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Amir Al-Momenin Hospital, Next to the School of Medicine, Basij Square (Sardasht), Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
Drnegar.gheytassi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Negar.Gheytassi
Position
RESIDENT
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Amir Al-Momenin Hospital, Next to the School of Medicine, Basij Square (Sardasht), Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
Drnegar.gheytassi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Negar Gheytassi
Position
RESIDENT
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Amir Al-Momenin Hospital, Next to the School of Medicine, Basij Square (Sardasht), Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
Drnegar.gheytassi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Students and researchers can use the data of this study.
From where data/document is obtainable
Researchers can contact the study author via email at Drnegar.gheytassi@gmail.com to receive data and information.
What processes are involved for a request to access data/document
Request information and data to the author via email Drnegar.gheytassi@gmail.com