Comparison of ferrous sulfate with ferrous sulfate and traditional medicine product (currant and pomegranate) effect on regulation of feritin in iron deficient women with normal hemoglobin
Target: Comparison of ferrous sulfate with ferrous sulfate and traditional medicine product (currant and pomegranate) effect on regulation of ferritin in iron deficient women with normal hemoglobin.
Design study: accidental and no blindness patient and researcher on the project. The intervention group will be compared with the control group.
Inclusion criteria: Hemoglobin above 12, ferritin below 50
Exclusion criteria: cardiovascular disease; thyroid or renal or hepatic disease; use supplement or Iron; hormone therapy; AUB; GI bleeding; abnormal CRP; smoking; menopause; pregnancy; and the factors related to abnormal red blood cells.
Intervention group will receive traditional product (currant and pomegranate) once a day at fast, plus ferrous sulfate up to three tablets per day.
Control group will receive ferrous sulfate, up to three tablets per day.
Follow up: every 3 month up to 9 month with control blood Tests, and monthly by phone.
Major outcome: the main outcome of the project is modified ferritin.
Measurement of CBC, CRP every three months, and on three occasions (up to 9 months) of patients is done. At each period, people treated themselves and Speed-called ferritin levels in the two groups will be compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015083123835N1
Registration date:2015-12-02, 1394/09/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-02, 1394/09/11
Registrant information
Name
Somaye Fatali
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2249 5995
Email address
s-fatali@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
College of Traditional Medicine, Sajadie Ave, Modiriat Ave, Kerman
Expected recruitment start date
2015-09-11, 1394/06/20
Expected recruitment end date
2016-06-19, 1395/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ferrous sulfate with ferrous sulfate and traditional medicine product (currant and pomegranate) effect on regulation of feritin in iron deficient women with normal hemoglobin
Public title
Helping to treatment of iron deficiency with traditional medicine product
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : women with HB > 12 and Ferritin < 50
Exclusion criteria: cardiovascular disease; thyroid or renal or hepatic disease; use supplement or Iron; hormone therapy; AUB; GI bleeding; abnormal CRP; smoking; menopause; pregnancy; and the factors related to abnormal red blood cells.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
----
Secondary trial Id
------
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Central Organization of Kerman University of Medical Sciences, Jomhuri islami Blv., Kerman
City
Kerman
Postal code
۷۶۱۵۶۸۷۱۳۴
Approval date
2015-09-09, 1394/06/18
Ethics committee reference number
ir.kmu.rec.1394.231
Health conditions studied
1
Description of health condition studied
Iron deficiency anemia
ICD-10 code
D50.9
ICD-10 code description
Iron deficiency anaemia, unspecified
Primary outcomes
1
Description
Ferritin
Timepoint
3 month
Method of measurement
Blood tests
2
Description
Hemoglobin
Timepoint
3 month
Method of measurement
Blood tests
Secondary outcomes
1
Description
Constipation
Timepoint
3 month
Method of measurement
The number of bowel movements per day
Intervention groups
1
Description
Intervention group: traditional product( currant and pomegranate) in fasting, plus ferrous sulfate up to three tablets per day
Category
Treatment - Drugs
2
Description
Control group: ferrous sulfate , up to three tablets per day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomaini Hospital, Hematological Clinic
Full name of responsible person
Somaye Fatali
Street address
Gharib Ave, Keshavars Blv, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Hale Tajoddini
Street address
College of Traditional Medicine, Sajadie Ave, Modiriat Ave, Kerman
City
Kerman
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, Kerman University of Medical Sciences