Protocol summary

Study aim
Determining the effect of iron supplementation with and without vitamin C on iron deficiency anemia, iron and hematological indices in patients with iron deficiency anemia
Design
Randomized Trial without blind assessment
Settings and conduct
Randomized Trial without blind assessment on anemic patients reffering ro razi hospital and touba clinic of Mazandaran University of Medical Science in 2025
Participants/Inclusion and exclusion criteria
Iron deficiency anemia and willingness to participate in the study and follow-up Taking iron or blood supplements within the past two months, acute infection, severe liver failure, gastrointestinal bleeding, taking multivitamins or supplements containing vitamin C within the past two months
Intervention groups
Control: Ferrous Glycine Sulphate: 80 mg for t months Intervention: Ferrous Glycine Sulphate: 80 mg plus vitamin c 250 mg daily for 2 months
Main outcome variables
Hb, Ferritin, Fe

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241127063874N1
Registration date: 2025-06-27, 1404/04/06
Registration timing: registered_while_recruiting

Last update: 2025-06-27, 1404/04/06
Update count: 0
Registration date
2025-06-27, 1404/04/06
Registrant information
Name
Zohreh Ehsani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 911 177 0256
Email address
zehsani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-06-22, 1404/04/01
Expected recruitment end date
2025-11-21, 1404/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of iron supplementation with and without vitamin c on iron deficiency anemia, iron and hematologic Indices of patients reffered to touba clinic
Public title
Vitamin c in anemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Iron deficiency anemia and willingness to participate in the study and follow-up
Exclusion criteria:
Receiving iron or blood supplements within the past two months, acute infection, severe liver failure, gastrointestinal bleeding, taking multivitamins or vitamin C supplements within the past two months
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Science
Street address
Moallem square
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Approval date
2024-01-09, 1402/10/19
Ethics committee reference number
IR.MAZUMS.REC.1402.591

Health conditions studied

1

Description of health condition studied
Anemia
ICD-10 code
D50
ICD-10 code description
Iron deficiency anemia

Primary outcomes

1

Description
Changes in Hb anf Ferritin and Fe
Timepoint
2 months after intervention
Method of measurement
Biochemical and ELISA methods

Secondary outcomes

empty

Intervention groups

1

Description
During this study, Ferrofort Duodenal tablets produced by the pharmaceutical company (Abidi, Ferrous Glycine Sulphate: 80 mg) will be prescribed to patients in two intervention groups. The dosage of the tablets in both groups is one tablet daily. This intervention will be carried out for two months.
Category
Treatment - Drugs

2

Description
In Vitamin C group in addition to daily Ferrous Glycine Sulphate: 80 mg, eurovital vitamin C 250 mg tablet is added to treatment. Once daily for two months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Touba clinic
Full name of responsible person
Zohreh Ehsani
Street address
Khazar Blvd, Khazar Sq , Sari.
City
Sari
Province
Mazandaran
Postal code
4816895474
Phone
+98 11 3329 1895
Email
zohreh.ehsani2017@gmail.com

2

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Zohreh Ehsani
Street address
Yousef reza St., Soleimani Highway, Ghaemshahr City.
City
Ghaemshahr
Province
Mazandaran
Postal code
4565686143
Phone
+98 11 4448 1073
Email
zohreh.ehsani2017@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Moallem square
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3448 4800
Email
aenayati1372@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Zohreh Ehsani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Razi street
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 911 177 0256
Fax
Email
Zehsani@mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zohreh Ehsani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Razi street
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 911 177 0256
Fax
Email
Zehsani@mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zohreh Ehsani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Razi street
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 911 177 0256
Fax
Email
Zehsani@mazums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
all collected deidentified IPD, IPD collected for the primary outcome measure only
When the data will become available and for how long
December 2025 for 1 month
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
Meta analysis
From where data/document is obtainable
Contact by email
What processes are involved for a request to access data/document
Approved project
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