The objective of this study was to compare daily and twice weekly iron supplementation on the anemia indices and side effects in mother and neonate (Cord) during pregnancy. 365 pregnant women were enrolled and randomly divided into two groups to receive iron daily (one 60 ferrous Sulfate tablet) or twice weekly (one 60 mg ferrous Sulfate tablets on Mondays and Thursdays). The adverse outcomes of iron Supplementation in mothers were recorded during pregnancy. Hemoglobin and Ferritin were checked from the umbilical cord sample and also from the mother’s blood sample at the birth time.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138802131641N4
Registration date:2010-03-27, 1389/01/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-03-27, 1389/01/07
Registrant information
Name
Azita Goshtasebi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3589
Email address
goshtasebi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University
Expected recruitment start date
2008-12-07, 1387/09/17
Expected recruitment end date
2009-09-08, 1388/06/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To compare daily and twice weekly iron supplementation on the anemia indices and side effects in mother and neonate (Cord) during pregnancy
Public title
To compare daily and twice weekly iron supplementation on the anemia indices and side effects in mother and neonate (Cord) during pregnancy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: pregnancy between 14-20 gestational weeks, age 18-35 years, hemoglobin 10.5-13.2g/dl, singleton pregnancy, BMI (19.8-26) kg/m2, No history of medical diseases during pregnancy
Exclusion criteria: hemoglobin less than 10.5 g/dl, preterm delivery before week 34, any condition that needs medical or surgical intervention
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
365
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tarbiat Modares university, Tehran
Street address
Nasr bridge, University Campus, Tehran
City
Tehran
Postal code
13116-14117
Approval date
2008-12-07, 1387/09/17
Ethics committee reference number
15071081
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
Complications of pregnancy
Timepoint
Since 20th week of gestational age till the end of pregnancy
Method of measurement
questionnaires filled by mothers
Secondary outcomes
1
Description
Hemoglobin level of mother
Timepoint
at the delivery time
Method of measurement
sampling from mother's blood
2
Description
Serum ferritin of mother
Timepoint
at the delivery time
Method of measurement
sampling from mother's blood
3
Description
Hemoglobin level of neonate
Timepoint
at the delivery time
Method of measurement
sampling from cord blood
4
Description
Serum Ferritin of neonates
Timepoint
at the delivery time
Method of measurement
sampling from cord blood
Intervention groups
1
Description
ferrous sulfate, 60 mg, one tablet per day, since 20th gestational week till the end of pegnancy
Category
Treatment - Drugs
2
Description
ferrous sulfate, 60 mg, one tablet on Mondays and Thursdays, since 20th gestational week till the end of pegnancy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital,
Full name of responsible person
Mozhgan Alizadeh
Street address
Imam Khomeini Hospital, Amir Mazandarany Street, Sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University, Tehran
Full name of responsible person
Dr Azita Goshtasbi
Street address
Nasr bridge, University Campus, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University, Tehran
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
University Tarbiat Modares Tehran
Full name of responsible person
Dr Azita Goshtasbi
Position
Assistant Professor of Midwifery
Other areas of specialty/work
Street address
Nasr bridge University campus Tehran
City
Tehran
Postal code
14117-13116
Phone
+98 21 8288 3589
Fax
+98 21 8288 3811
Email
goshtasebi@modares.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr Azita Goshtasbi
Position
Assistant Professor of Midwifery
Other areas of specialty/work
Street address
Nasr bridge University Campus Tehran
City
Tehran
Postal code
14117-13116
Phone
+98 21 8288 3589
Fax
+98 21 8288 3811
Email
goshtasebi@modares.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
ِِDr Azita Goshtasbi
Position
Assistant Professor of Midwifery
Other areas of specialty/work
Street address
Nasr bridge University Campus Tehran
City
Tehran
Postal code
14117-13116
Phone
+98 21 8288 3589
Fax
+98 21 8288 3811
Email
goshtasebi@modares.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)