A randomized placebo-controlled trial to determine the effect of iron supplementation on hematological indices in pregnant women with hemoglobin ≥13.2 g/dl
The objective of our study is to investigate the effect of iron supplementation on hematological indices in pregnant women with hemoglobin more than or equal to 13.2 g/dl. In a randomized, double-blind, placebo-controlled trial eighty-seven pregnant women with Hb≥13.2 g/dl and ferritin≥14.3g/dl were selected with gestational age 13-18 weeks. Each woman received either 50 mg ferrous sulfate daily or placebo during pregnancy. Hb, HCT, MCV, MCH, MCHC, and RBC were measured in 24-28 and 32-36 gestational weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138710181531N1
Registration date:2009-11-08, 1388/08/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-11-08, 1388/08/17
Registrant information
Name
Zeinab Hamzehgardeshi
Name of organization / entity
Tarbiat Modarres University
Country
Iran (Islamic Republic of)
Phone
+98 15 1324 6883
Email address
hamzeh@razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modarres University
Expected recruitment start date
2002-03-20, 1380/12/29
Expected recruitment end date
2003-03-20, 1381/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized placebo-controlled trial to determine the effect of iron supplementation on hematological indices in pregnant women with hemoglobin ≥13.2 g/dl
Public title
A randomized placebo-controlled trial to determine the effect of iron supplementation on hematological indices in pregnant women with hemoglobin ≥13.2 g/dl
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women with Hb ≥ 13.2 g/dl in the early stage of the second trimester, body mass index (BMI) between 19.8 and 26 kg/m2, single pregnancy, age between 17 and 35 years
Exclusion criteria: Falling Hb to less than 10.5 g/dl in the second trimester or 11 g/dl in the third trimester, history of any renal, hepatic, thyroid, or cardiac diseases, presence of diabetes, asthma, hypertension, or inflammatory diseases, presence of severe nausea and vomiting of pregnancy, smoking, substance abuse, history of threatened abortion
Age
From 17 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
87
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tarbiat Modarres University
Street address
Gisha, Jalale Ale Ahmad highway, Tehran.
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
103/5364
Health conditions studied
1
Description of health condition studied
Pregnant women of high hemoglobin
ICD-10 code
O28.0
ICD-10 code description
Abnormal haematological finding on antenatal screening of mother
Primary outcomes
1
Description
Hematologic indices
Timepoint
Baseline, at gestational weeks 24 -28 and 32-36
Method of measurement
Cell Blood Count with sismex k1000
Secondary outcomes
empty
Intervention groups
1
Description
Ferrous sulfate, 150 mg tablet with 50 mg ferrous elemental, daily, from 20th gestational week to the end of pregnancy
Category
Prevention
2
Description
Placebo tablets, one tablet daily, from 20th gestational week to the end of pregnancy
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Street address
North Karegar Ave., Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
Baghiatollah hospital
Full name of responsible person
Street address
Wanak, Mollasadra Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modarres University
Full name of responsible person
Vice-chancellor for Research
Street address
Gisha, Jalale Ale Ahmad highway, 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 Modarres University
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
Tarbiat Modarres University,Tehran University medical science
Full name of responsible person
Zeinab Hamzehgardeshi
Position
Ph.D student
Other areas of specialty/work
Street address
Gisha, Jalale Ale Ahmad highway, Tehran.
City
Tehran
Postal code
Phone
+98 15 1324 6883
Fax
Email
hamzeh@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modarres University, Tehran University of Medical Siences
Full name of responsible person
Zeinab Hamzehgardeshi
Position
Ph.D student
Other areas of specialty/work
Street address
Gisha, Jalale Ale Ahmad highway, Tehran.
City
Tehran
Postal code
Phone
+98 15 4324 6883
Fax
Email
hamzeh@razi.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat modarres University, Tehran University of Medical Sience
Full name of responsible person
Zeinab Hamzehgardeshi
Position
Ph.D Student
Other areas of specialty/work
Street address
Gisha, Jalale Ale Ahmad highway, Tehran.
City
Tehran
Postal code
Phone
+98 15 1324 6883
Fax
Email
hamzeh@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)