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Trial registered on ANZCTR


Registration number
ACTRN12615000690550
Ethics application status
Approved
Date submitted
15/06/2015
Date registered
2/07/2015
Date last updated
6/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Iron bioavailability from an instant milk beverage containing FERRI PRO Trademark
Scientific title
Assessment of iron absorption from a novel iron fortificant, FERRI PRO Trademark in an instant milk drink compared with ferrous sulphate in healthy adult females.
Secondary ID [1] 286899 0
Nil
Universal Trial Number (UTN)
U1111-1171-1323
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron deficiency 295305 0
Condition category
Condition code
Diet and Nutrition 295575 295575 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Iron absorption from isotopically Fe labelled FERRI PRO Trademark was directly compared against iron absorption from isotopically Fe labelled ferrous sulphate in a randomized cross-over study.

An instant milk drink (250 ml) containing isotopically labelled FERRI PRO Trademark (2.4 mg fortification iron per serving) was fed twice after an overnight fast with both feedings being separated by a 3 h interval. Emptied glasses were washed twice with 25 ml of milli-q water. Participants consumed the washings in order to ensure complete intake of the drink and the isotopically labelled fortificant. Participants were asked not to eat or drink between the two servings and for 3 h following the second administration. All feedings were performed under close supervision of the investigators.

Half of the participants were fed the FERRI PRO Trademark on the first day followed by the comparator ferrous sulphate on the second day whilst the other half of the participants were fed the comparator on the first day and FERRI PRO Trademark on the second day.
Intervention code [1] 292081 0
Treatment: Other
Comparator / control treatment
An instant milk drink (250 ml) containing isotopically labelled ferrous sulphate (2.4 mg fortification iron per serving) was fed twice after an overnight fast with both feedings being separated by a 3 h interval. Emptied glasses were washed twice with 25 ml of milli-q water. Participants consumed the washings in order to ensure complete intake of the drink and the isotopically labelled fortificant. Participants were asked not to eat or drink between the two servings and for 3 h following the second administration. All feedings were performed under close supervision of the investigators.
Control group
Active

Outcomes
Primary outcome [1] 295287 0
% iron absorption determined via erythrocyte incorporation of isotopic labels (57Fe and 58Fe).
Timepoint [1] 295287 0
14 days after the intake of the last test meal.
Secondary outcome [1] 315269 0
Nil
Timepoint [1] 315269 0
Nil

Eligibility
Key inclusion criteria
Healthy, non-anaemic, non-iron deficient (serum ferritin concentrations are > 12 ug/L and < 150 ug/L; haemoglobin > 120 g/L.
Stable body weight and normal body mass index (18.5-25 kg/m2).
Caucasian/European descent.
C-reactive protein concentrations < 5 mg/L.
Minimum age
19 Years
Maximum age
40 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of gastrointestinal disorders including ulcers or gastrointestinal surgery.
Established health problems likely to influence iron status such as inflammatory bowel disease, endocrine disorders, diabetes, celiac disease, red blood cell disorders, menorrhagia, haemorrhoids, haematuria or have had malaria.
Donated blood or had significant blood loss during the 6 months prior to the study.
Participated in a study involving administration of stable isotopes.
Participated in another clinical trial during the three months leading up to the start of the study.
Consumed antibiotics one month before the study and/or during the study.
Be anaemic
Be pregnant or have been pregnant in the 12 months prior to the study.
Be breastfeeding.
Regular consumers of iron supplements (define as >20 mg elemental iron at least 3-4 times per week for one month prior to the trial.
Smoke cigarettes.
Consume more than two units of alcohol per day.
Vegetarian or vegan.
Allergies to dairy products.
On a controlled diet or dietary weight loss regimen within 4 weeks before and/or during the study.
Experienced significant weight loss during the 6 months prior to the study.
Taking any medications regularly, including antacids, except oral contraceptives.
Have an aversion to blood sample collection.

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)
Allocation concealment was done by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6970 0
New Zealand
State/province [1] 6970 0
Manawatu

Funding & Sponsors
Funding source category [1] 291465 0
University
Name [1] 291465 0
Massey University
Address [1] 291465 0
Private Bag 11222
Palmerston North 4442
Country [1] 291465 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Tennent Drive
Palmerston North 4474
Manawatu
Country
New Zealand
Secondary sponsor category [1] 290145 0
None
Name [1] 290145 0
Address [1] 290145 0
Country [1] 290145 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293014 0
Massey University Human Ethics Committee
Ethics committee address [1] 293014 0
Research Ethics Office
Massey University
Tennent Drive
Palmerston North 4474
Ethics committee country [1] 293014 0
New Zealand
Date submitted for ethics approval [1] 293014 0
11/02/2014
Approval date [1] 293014 0
09/04/2014
Ethics approval number [1] 293014 0
14/06

Summary
Brief summary
Iron deficiency and consequently iron deficiency anaemia develops when iron intake does not meet iron requirements over the long term. Iron fortification of foods is considered to be the most cost-effective intervention to combat iron deficiency. Fortification of foods can however be a challenge with problems ranging from undesirable taste issues to decreased nutrient absorption. The Riddet Institute has developed an iron fortificant known as FERRI PRO Trademark that allows the addition of iron to food products with minimal effect on sensory characteristics and product shelf-life. The purpose of this project is to evaluate the bioavailability of iron (how much iron is absorbed and utilised by the body) from a FERRI PRO Trademark fortified instant milk beverage.

A stable isotope technique, based on the analysis of the incorporation of stable (non-radioactive) isotopes into red blood cells will be used to determine bioavailability. Participants will be required to consume two iron fortified milk-based beverages on two consecutive days. The two iron fortificants, FERRI PRO Trademark and ferrous sulphate will be prepared using stable iron isotopes 57Fe and 58Fe to allow us to track the incorporation of the iron into the blood cells. Blood samples will be collected at the start and 14 days after the consumption of the drinks. Analysis of these samples will tell us how much iron from each beverage has been absorbed and a comparison to be made.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58034 0
Dr Sharon Henare
Address 58034 0
Riddet Institute
Massey University
Private Bag 11222
Palmerston North 4442
Country 58034 0
New Zealand
Phone 58034 0
+64 6 3569099 ext 84289
Fax 58034 0
+64 6 3505655
Email 58034 0
S.J.Henare@massey.ac.nz
Contact person for public queries
Name 58035 0
Dr Sharon Henare
Address 58035 0
Riddet Institute
Massey University
Private Bag 11222
Palmerston North 4442
Country 58035 0
New Zealand
Phone 58035 0
+64 6 3569099 ext 84289
Fax 58035 0
+64 6 3505655
Email 58035 0
S.J.Henare@massey.ac.nz
Contact person for scientific queries
Name 58036 0
Dr Sharon Henare
Address 58036 0
Riddet Institute
Massey University
Private Bag 11222
Palmerston North 4442
Country 58036 0
New Zealand
Phone 58036 0
+64 6 3569099 ext 84289
Fax 58036 0
+64 6 3505655
Email 58036 0
S.J.Henare@massey.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary