Evaluation of the influence of nano-iron-enriched honey supplements on ferritin status in women with iron deficiency
Design
Clinical trial with control group, community-based, with parallel groups, double blind, randomized groups
Settings and conduct
Mashhad University of Medical Sciences
double blind clinical trial
Participants/Inclusion and exclusion criteria
Hemoglobin higher than 12 mg / dl and ferritin less than 15 ng / ml as non-anemic patients with iron deficiency
Age between 18 to 60 years
Voluntary consent
Intervention groups
Case group received one capsule containing iron and honey (50 mg nano-elemental iron + honey) daily for 6 month and control group received one ferrous sulfate capsule in simillar shap.
Main outcome variables
Serum ferritin level
Serum iron level
Serum hemoglobin level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180630040293N1
Registration date:2018-07-16, 1397/04/25
Registration timing:prospective
Last update:2018-07-16, 1397/04/25
Update count:0
Registration date
2018-07-16, 1397/04/25
Registrant information
Name
Mohammadreza Kazemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3250 0200
Email address
kazemimr871@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Influence of nano-iron-enriched honey supplements on ferritin status in women with iron deficiency
Public title
Influence of nano-iron-enriched honey supplements on ferritin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hemoglobin higher than 12 mg / dl and ferritin less than 15 ng / ml as non-anemic patients with iron deficiency
Age between 18 to 60 years
Voluntary consent
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Based on random permutation
Blinding (investigator's opinion)
Triple blinded
Blinding description
Intervention is unknown to the research participant, the individual who administer the treatment, and the individual who assess the outcomes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9431744551
Approval date
2017-03-04, 1395/12/14
Ethics committee reference number
IR.MUMS.sm.REC.1395.347
Health conditions studied
1
Description of health condition studied
Iron defetiency
ICD-10 code
D50
ICD-10 code description
Iron deficiency anaemia
Primary outcomes
1
Description
Serum ferritin level
Timepoint
Every three months
Method of measurement
questionnaire
2
Description
Serum iron level
Timepoint
Every three months
Method of measurement
questionnaire
3
Description
Serum hemoglobin level
Timepoint
Every three months
Method of measurement
questionnaire
Secondary outcomes
1
Description
ِDrug side effects
Timepoint
Every three months
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Received one capsule containing iron and honey (50 mg nano-elemental iron + honey) daily for 6 month
Category
Treatment - Drugs
2
Description
Control group: Received one ferrous sulfate capsule in simillar shap, daily for 6 month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isar clinic of Mashhad University of Medical Sciences
Full name of responsible person
Abolghasem Allahyari
Street address
Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9431744551
Phone
+98 51 3802 2000
Email
AllahyariA@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mrs. Esmati
Street address
Daneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
91735951
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Parmis Momtaz
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Daneshgah Ave. Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9431744551
Phone
+98 519128890200
Email
momtazp931@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abolghasem Allahyari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Daneshgah Ave. Imam Reza Hospital
City
mashhad
Province
Razavi Khorasan
Postal code
9431744551
Phone
+98 51 3802 2000
Email
AllahyariA@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abolghasem Allahyari
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
ِDaneshgah Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9431744551
Phone
+98 51 3802 2000
Email
AllahyariA@mums.ac.ir
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
Sharing will be done after the end of the study
When the data will become available and for how long
Start of access from the second half of 1398
To whom data/document is available
for all.
Under which criteria data/document could be used
For studying and teaching
From where data/document is obtainable
Email
What processes are involved for a request to access data/document