The effect of synbiotic capsule on the status of hematologic indices of anemia in women with iron deficiency anemia referring to in City Level Labs Mahallat
The effect of synbiotic capsule on hematologic status of anemia in with iron deficiency anemia referring to Imam Khomeini Hospital in Mahalat
Design
Trial without control group, simple randomization, without blinding
Settings and conduct
Workplace Design: Hospital
Methods: 10% of the sample size was calculated and referrals from cases with iron deficiency anemia with a hemoglobin concentration of 10 to 12 mg / dl were recorded from the total list with a number ranging from 1 to 9. The baseline and the multiples of the sample will continue. The general information questionnaire, oral frequency questionnaire and ethical consent will be completed and a training session on dietary intake and supplement intake will be held for all women. All people are asked to notify the practitioner of the plan in the event of illness, medication, or any form of supplementation by the physician, or any changes that may affect the plan. Anthropometric measurements (including weight and height), biochemical variables (RBC, HB, HCT, MCV, MCH, MCHC, RDW, Ferritin, IRON, TIBC) and end of study will be reviewed. All women receive 2 capsules of synbiotic daily for 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women 20-35 years old, with hemoglobin concentration greater than 12-12 mg / dl
Exclusion criteria: no supplementation, blood loss within 3 months, disease
Intervention groups
Synbiotics Supplement
Main outcome variables
RBC ، HB ، HCT ، MCV ، MCH ، MCHC ، RDW index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190807044465N1
Registration date:2019-10-26, 1398/08/04
Registration timing:registered_while_recruiting
Last update:2019-10-26, 1398/08/04
Update count:0
Registration date
2019-10-26, 1398/08/04
Registrant information
Name
sodabeh amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4322 3026
Email address
sodabehamiry@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of synbiotic capsule on the status of hematologic indices of anemia in women with iron deficiency anemia referring to in City Level Labs Mahallat
Public title
The effect of synbiotic on the status of indices of anemia in women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women with iron deficiency anemia referred to in City Level Labs Mahallat
Intervention group: Women 20-35 years old with iron deficiency anemia/ Synbiotic supplement as Familact capsule contains high levels (109 CFU) of different probiotics prescribed in doses of 500 mg / 2 daily / Bio Fermentation Company - Iran
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Mahallat
Full name of responsible person
Sodabeh Amiri
Street address
Jomhori Street
City
Mahallat
Province
Markazi
Postal code
3781666369
Phone
+98 86 4322 2081
Fax
+98 86 4322 4288
Email
Sodabehamiry@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Azizi Soleiman
Street address
Jomhori Street
City
Mahallat
Province
Markazi
Postal code
3781666369
Phone
+98 86 4322 3026
Fax
+98 86 4322 6979
Email
Sodabehamiry@yahoo.com
Grant name
Grant code / Reference number
640
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Arak Medical University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Soudabeh Amiri
Position
Expert
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
jomhori street
City
mahallat
Province
Markazi
Postal code
3781666369
Phone
+98 86 4322 3026
Fax
+98 86 4322 6979
Email
sodabehamiry@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Azizi Soleiman
Position
Science Committee
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golestan street
City
Arak
Province
Markazi
Postal code
38181-46851
Phone
+98 86 3366 2024
Fax
+98 86 3368 6443
Email
Fatemehazizi87@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Rahmani
Position
Expert
Latest degree
Master
Other areas of specialty/work
Health Technology Assessment
Street address
Jomhori
City
Mahallat
Province
Markazi
Postal code
37816-66369
Phone
+98 86 4322 3026
Fax
+98 86 4322 6979
Email
Rahmani.mahbobeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
BMI, Biochemical index
When the data will become available and for how long
3 Month
To whom data/document is available
Researchers plan
Under which criteria data/document could be used
prevention
From where data/document is obtainable
laboratory
What processes are involved for a request to access data/document