The evaluation of the effect of the time of administration of oral iron product on the amount of hemoglobin increase in patients with iron deficiency anemia
Design
A double-blind, placebo-controlled, randomized clinical trial will be performed in parallel on 196 patients. Blocked randomization method was used for randomization
Settings and conduct
Screening and confirmation of study inclusion criteria by a physician from among the patients referred to the clinics of Imam Reza and Ghaem hospitals, then allocation of patients to two groups A and B based on the randomization list.
Participants/Inclusion and exclusion criteria
The diagnosis of iron deficiency anemia based on iron evaluation indices including serum iron level, ferritin and transferrin saturation capacity
Hemoglobin level less than or equal to 11 mg/dL
Intervention groups
In the intervention group, iron tablets are prescribed in the morning at 10 o'clock and placebo in the evening at 6 o'clock.
Main outcome variables
Increase in hemoglobin level, and iron profile
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210503051166N2
Registration date:2023-02-01, 1401/11/12
Registration timing:prospective
Last update:2023-02-01, 1401/11/12
Update count:0
Registration date
2023-02-01, 1401/11/12
Registrant information
Name
Omid Arasteh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3180 1760
Email address
arasteho@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the effect of administration time of oral Iron preparations on hemoglobin response in patients with Iron deficiency anemia
Public title
The effect of administration time of oral iron preparations on hemoglobin response
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with iron deficiency anemia based on iron profile study such as serum iron, ferritin, and transferrin saturation percent
Hemoglobin level less than 11 mg/dl
Not suffering from chronic liver disease (normal bilirubin, LFT<2 times normal), or other chronic inflammatory diseases based on initial evaluation
Not suffering from active malignancy based on initial evaluation
Not suffering from active infection based on initial evaluation
Not suffering from any of the malabsorption syndromes based on the initial evaluation
Patients with cardiovascular risk factors
Exclusion criteria:
Suffering from any chronic kidney disease, liver disease, all types of cancer, infections and autoimmune diseases
The patient's lack of consent to participate in the plan
Having dyspepsia and intolerance to iron food products
High CRP levels at study entry
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
196
Randomization (investigator's opinion)
Randomized
Randomization description
A replacement block using the site https://www.sealedenvelope.com with the explanation that each block has 4 and 6 members and the shape of the blocks can be as follows:
[ABAB], [ABBA, [AABB], [BBAA], [BABA][BAAB]
Code A corresponds to the intervention group and code B corresponds to the control group. The aforementioned site randomly selects nineteen blocks from four blocks and twenty blocks from six blocks. So, finally 196 patients are included in the study.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Triple Blinded
The patients of the control and intervention groups are randomly divided into two groups based on the codes that were designed by the random block method. These codes are designed by another person who is not aware of the study and are provided to the participants using closed letters. The researcher, patients, physicians responsible for the patients and the person who is responsible for statistical analysis do not know about the codes related to the control and intervention groups until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
No. 16, 21th Edalat avenue., Ahmadabad blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9176614889
Approval date
2022-12-31, 1401/10/10
Ethics committee reference number
IR.MUMS.REC.1401.337
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
Increase in hemoglobin level
Timepoint
before intervention and 4 weeks after intervention
Method of measurement
Hemoglobin concentration in complete blood count test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, Iron tablets made by abidi company (Ferofort duodenal) which included 80 mg elemental iron are prescribed in the morning at 10 o'clock and placebo tablets are prescribed in the evening at 6 o'clock. Patients use these pills every day for a month. Hemoglobin level testing is done for patients before the start of the study and after one month.
Category
Treatment - Drugs
2
Description
Control group: In the intervention group, placebo tablets are prescribed in the morning at 10 o'clock and Iron tablets made by abidi company (Ferofort) which included 80 mg elemental iron are prescribed in the evening at 6 o'clock. Patients use these pills every day for a month. Hemoglobin level testing is done for patients before the start of the study and after one month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Omid Arasteh
Street address
Azadi Square, University Campus, Faculty of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1760
Email
Arasteho@mums.ac.ir
Web page address
https://pharmacy.mums.ac.ir/
2
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Omid Arasteh
Street address
Azadi Square, University Campus, Faculty of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1760
Email
Arasteho@mums.ac.ir
Web page address
https://pharmacy.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Khalil Abnous
Street address
میدان آزادی ،پردیس دانشگاه ، دانشکده داروسازی
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1112
Email
AbnousKH@mums.ac.ir
Web page address
https://pharmacy.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Omid Arasteh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Clinical Pharmacy
Street address
Azadi Square, University Campus, Faculty of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1760
Email
Arasteho@mums.ac.ir
Web page address
https://pharmacy.mums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Omid Arasteh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Clinical Pharmacy
Street address
Azadi Square, University Campus, Faculty of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1760
Email
Arasteho@mums.ac.ir
Web page address
https://pharmacy.mums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Omid Arasteh
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Specialist
Other areas of specialty/work
Clinical Pharmacy
Street address
Azadi Square, University Campus, Faculty of Pharmacy
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1760
Email
Arasteho@mums.ac.ir
Web page address
https://pharmacy.mums.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
All participants' information will be kept strictly confidential during and after the study
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
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available