(1) Objectives: Comparing the effectiveness of a new form of intravenous iron (ferric carboxymaltose) with the oral form ferrous sulfate in Iran. (2) Design: Sixty colon cancer patients who admit in single clinical center will be randomly divided into two groups based on balanced block randomization method. (3) Setting and conduct: After dividing, patients in group I will be treated two months duration, but group II patients will receive one drug dose. Lab test will be repeated 8 weeks in both groups. (4) Participants including colon cancer patients with chronic iron deficiency anemia. (5) Intervention: Patients will be treated with oral iron tablets and intravenous iron injection in group I and II, respectively. (6) Primary outcome variables include hemoglobin and ferritin serum level changes in all patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092111560N9
Registration date:2015-12-12, 1394/09/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-12, 1394/09/21
Registrant information
Name
Tayeb Ramim
Name of organization / entity
Sina Trauma and Surgery Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 0000
Email address
tayebramim@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of ferric carboxymaltose and oral iron in treatment of chronic iron deficiency anemia in colon cancer patients
Public title
Effect of intravenous iron in the treatment of chronic iron deficiency anemia in colon cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : colon cancer; chronic iron deficiency anemia.
Exclusion criteria: severe drug reaction; lost to follow up; low level of consciousness due to underlying disease and death.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Iran University of Medical Science
Street address
Central devision of Iran University of Medical Sciences, Hemat gateway
City
Tehran
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.IUMS.REC.139527216
Health conditions studied
1
Description of health condition studied
Iron deficiency anaemia
ICD-10 code
D-50
ICD-10 code description
Iron deficiency anaemia
Primary outcomes
1
Description
Hemiglobin
Timepoint
Pre treatment; 8 weeks following end of treatment
Method of measurement
gram/ deciliter using of blood sample
2
Description
Ferritin
Timepoint
Pre treatment; 8 weeks following end of treatment
Method of measurement
nanogram/ mililiter using of blood sample
Secondary outcomes
empty
Intervention groups
1
Description
1500 mg bolus injection of ferric carboxymaltose (Injectafer®)
Category
Treatment - Drugs
2
Description
65mg/TDS ferrous sulfate (Daru Yab. Co) until two month, 180 tables
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Naffise Ansari Nejad
Street address
Niayesh St, Tohid Sq.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Seeid Ali Javad Mosavi
Street address
Central devision of Iran University of Medical Sciences, Hemat gateway
City
Teharn
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Naffiseh Ansarinejad
Position
MD
Other areas of specialty/work
Street address
Central devision of Iran University of Medical Sciences, Hemat gateway
City
Tehran
Postal code
Phone
+98 21 6631 0000
Fax
Email
slr_1975@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Naffiseh Ansarinejad
Position
MD
Other areas of specialty/work
Street address
Central devision of Iran University of Medical Sciences, Hemat gateway
City
Tehran
Postal code
Phone
+98 21 6633 1000
Fax
Email
slr_1975@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sina Trauma and Surgery Research Center, Tehran University of Medical Sciences
Full name of responsible person
Teyeb Ramim
Position
MD
Other areas of specialty/work
Street address
Sina Hospital, Hasan Abad Sq, Imam khomeini Ave.
City
Tehran
Postal code
Phone
+98 21 6675 7001
Fax
Email
tayebramim@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)