Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000232730
Ethics application status
Approved
Date submitted
25/02/2013
Date registered
27/02/2013
Date last updated
27/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can written information and communication through email and text messages improve knowledge of dietary iron, iron intake, and iron status in women with mild iron deficiency?
Scientific title
The effect of written information and communication through email and text messages on knowledge of dietary iron, iron intake, and biomarkers of iron status in premenopausal women with low iron stores
Secondary ID [1] 281971 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron deficiency 288398 0
Condition category
Condition code
Diet and Nutrition 288746 288746 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a 12-week randomised controlled trial testing one intervention. Participants in the intervention group will receive a booklet containing factsheets about iron and a goal system promote dietary habits that may maximise iron absorption. The goal system encourages participants to 1) eat two iron-fortified products each day, 2) eat 50 mg of vitamin C with meals, 3) using a point system where foods are assigned points depending on iron content, consume at least 12 points per day, and 4) drink coffee/tea away from meals. Participants will be encouraged to follow the goals through weekly emails and text messages.
Intervention code [1] 286540 0
Lifestyle
Intervention code [2] 286602 0
Treatment: Other
Comparator / control treatment
The control group will receive an Australian Guide to Healthy Eating booklet and a goal system will encourage participants to: 1) limit intake of saturated fat, 2) choose wholegrain foods, 3) reduce sodium intake, and 4) aim to eat 2 serves of fruit and 5 serves of vegetables daily over the 12 week period. Participants will be encouraged to follow the goals through weekly emails and text messages.
Control group
Active

Outcomes
Primary outcome [1] 288952 0
Serum ferritin will be measured as a biomarker of iron status. Dorevitch Pathology (Melbourne) will collect and analyse fasting venous blood samples from participants. Serum ferritin will be measured using the ADVIA Centaur (Registered Trademark) Ferritin Assay (Siemens Healthcare Diagnostics, Deerfield, Illinois, US)
Timepoint [1] 288952 0
Baseline and 12 weeks
Primary outcome [2] 288953 0
Knowledge of dietary iron will measured using a 12-item multiple choice quiz
Timepoint [2] 288953 0
Baseline and 12 weeks
Primary outcome [3] 288954 0
Intake of dietary iron will be measured using a short diet checklist
Timepoint [3] 288954 0
Baseline, monthly through the trial, and 12 weeks
Secondary outcome [1] 301430 0
Nil
Timepoint [1] 301430 0
Nil

Eligibility
Key inclusion criteria
Premenopausal women with serum ferritin <20 micrograms/L and haemoglobin equal to or greater than 120 g/L
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Post-menopausal
Currently a blood donor or have donated blood in the past 2 years
Currently pregnant or breastfeeding or have been in the past 2 years
Haemoglobin <120 grams/L
Serum ferritin equal to or greater than 20 micrograms/L

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study will be advertised publically using flyers and advertisements in newspapers and newsletters. A fasting blood test will be used to determine whether participants have serum ferritin <20 micrograms/L and haemoglobin equal to or greater than 120 g/L.

Participants will be randomised to the control or intervention groups following stratification by vegetarian status using the computer program MINIM. Allocation will not be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The computer software MINIM will be used to randomise allocation and to stratify allocation according to vegetarian status.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics to examine characteristics at baseline and 2x2 ANOVA to test whether the trial affected iron status, knowledge, or intake.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/01/2013
Actual
17/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286796 0
University
Name [1] 286796 0
Deakin University
Country [1] 286796 0
Australia
Funding source category [2] 286797 0
Commercial sector/Industry
Name [2] 286797 0
Meat and Livestock Australia
Country [2] 286797 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 285587 0
Commercial sector/Industry
Name [1] 285587 0
Meat and Livestock Australia
Address [1] 285587 0
Address of funding source:
Level 1, 165 Walker Street
North Sydney NSW 2060
Country [1] 285587 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288863 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 288863 0
Ethics committee country [1] 288863 0
Australia
Date submitted for ethics approval [1] 288863 0
Approval date [1] 288863 0
17/04/2012
Ethics approval number [1] 288863 0
2012-046

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37922 0
A/Prof Lynn Riddell
Address 37922 0
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway, Burwood VIC 3125
Country 37922 0
Australia
Phone 37922 0
+613 9251 7270
Fax 37922 0
Email 37922 0
[email protected]
Contact person for public queries
Name 37923 0
Karen Lim
Address 37923 0
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway, Burwood VIC 3125
Country 37923 0
Australia
Phone 37923 0
+613 9251 7286
Fax 37923 0
Email 37923 0
[email protected]
Contact person for scientific queries
Name 37924 0
Karen Lim
Address 37924 0
School of Exercise and Nutrition Sciences
Deakin University
221 Burwood Highway, Burwood VIC 3125
Country 37924 0
Australia
Phone 37924 0
+613 9251 7286
Fax 37924 0
Email 37924 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.