Comparison effect of daily versus intermittent dose of iron supplement on the blood indices, serum level of iron, ferritin and zinc in healthy pregnant women
This clinical trial study aimed to compare daily and intermittent dose of iron supplementation on blood indices, Iron, Zinc and Ferritin among 146 healthy pregnant women. Inclusion criteria for pregnant women are ages 17- 40, being less than 20 weeks of gestation, having hemoglobin higher than 11 g/dl, and no symptoms of minor β Thalassemia or any other diagnosed internal disease. Furthermore, those with history of abortion or more than 2 deliveries will be excluded from the study.
All participants at the first admission in the Gynecology and Obstetrics Clinics will be randomly divided in 2 groups. Initial blood samples (5 ml) will be drawn at 10-14 weeks of pregnancy (first trimester) to control CBC, Fe, Zinc and Ferritin. From 20th weeks of pregnancy
Case groups will receive daily dose of iron supplement (50 mg/day) and those in control group will receive intermittent dose of iron supplement (three times /week) (50 mg/each time). Then blood samples will be taken from all subjects at trimester two (26-28 weeks) and three (34-37 weeks) and the results will be compared with the results of trimester one. Additionally, results will be compared between two groups. All the subjects will be monthly followed up regarding consumption of the medication and its side effects.
General information
Acronym
Iron supplementation and pregnancy
IRCT registration information
IRCT registration number:IRCT2012082810682N1
Registration date:2012-10-08, 1391/07/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-10-08, 1391/07/17
Registrant information
Name
Haydeh Alaoddolehei
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 4274
Email address
h.aloddoleh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
The research council of Babol University of Medical Sciences.
Expected recruitment start date
2012-10-11, 1391/07/20
Expected recruitment end date
2013-06-20, 1392/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of daily versus intermittent dose of iron supplement on the blood indices, serum level of iron, ferritin and zinc in healthy pregnant women
Public title
Effects of different dose of Iron in prevention of anemia in healthy pregnant women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Healthy pregnant women; Less than 20 weeks of gestation; More than 11 g% hemoglobin level.
Exclusion criteria: People with β minor thalassemia; Diagnosed internal diseases; Abortion; More than 2 delivery.
Age
From 17 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
146
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
Babol University of Medical Sciences
Street address
Ganj-afroz Ave.
City
Babol
Postal code
4717641367
Approval date
2012-09-09, 1391/06/19
Ethics committee reference number
7074.30.g.p
Health conditions studied
1
Description of health condition studied
pregnancy
ICD-10 code
O99.0
ICD-10 code description
Anaemia complicating pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Hb
Timepoint
20, 26-28 and 34-37 weeks of gestation
Method of measurement
coulter counter: g%
2
Description
MCV
Timepoint
20, 26-28 and 34-37 weeks of gestation
Method of measurement
colter counter: fl
3
Description
RBC
Timepoint
20, 26-28 and 34-37 weeks of gestation
Method of measurement
colter counter: mil/mm3
4
Description
Iron
Timepoint
20, 26-28 and 34-37 weeks of gestation
Method of measurement
colorimetric: micg%
5
Description
Ferritin
Timepoint
20, 26-28 and 34-37 weeks of gestation
Method of measurement
ELISA: ng/ml
6
Description
Zinc
Timepoint
20, 26-28 and 34-37 weeks of gestation
Method of measurement
colorimetric: micg%
Secondary outcomes
empty
Intervention groups
1
Description
control: daily dose of iron supplementation (50 mg/dose) from 20 weeks of gestation
Category
Prevention
2
Description
Case: 3 times of iron supplementation in week (50 mg/dose) from 20 weeks of gestation.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology and Obestetrics clinics
Full name of responsible person
Haydeh Alaoddolehei
Street address
Keshavarz Blvd, Ganj-Afrooz Ave, Karegar square
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ali Bijani
Street address
Ganj afroz Ave.
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Farahnaz Sadighian
Position
lab technician
Other areas of specialty/work
Street address
Ganj Afroz Ave.
City
Babol
Postal code
Phone
+98 11 1223 4274
Fax
Email
f.sadigh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol Univiersity of Medical Sciences
Full name of responsible person
Haydeh Alaoddolehei
Position
MS.c/Academic membership
Other areas of specialty/work
Street address
Ganj Afroz Ave
City
Babol
Postal code
Phone
+98 11 1223 4274
Fax
Email
alaee_ha@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Haydeh Alaoddolehei
Position
Ms.c/academic membership
Other areas of specialty/work
Street address
Keshavarz Blvd, Ganj-Afrooz Ave, Karegar square
City
Babol
Postal code
47176 41367
Phone
+98 11 1223 4274
Fax
Email
alaee_ha@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)