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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]

Nil

Universal Trial Number (UTN)

U1111-1171-1323

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Iron deficiency

Condition category

Condition code

Diet and Nutrition

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]

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]

% iron absorption determined via erythrocyte incorporation of isotopic labels (57Fe and 58Fe).

Timepoint [1]

14 days after the intake of the last test meal.

Secondary outcome [1]

Nil

Timepoint [1]

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

Sex

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

5/05/2014

Actual

12/05/2014

Date of last participant enrolment

Anticipated

16/05/2014

Actual

16/05/2014

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Manawatu

Funding & Sponsors

Funding source category [1]

University

Name [1]

Massey University

Address [1]

Private Bag 11222
Palmerston North 4442

Country [1]

New Zealand

Primary sponsor type

University

Name

Massey University

Address

Tennent Drive
Palmerston North 4474
Manawatu

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Massey University Human Ethics Committee

Ethics committee address [1]

Research Ethics Office
Massey University
Tennent Drive
Palmerston North 4474

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

11/02/2014

Approval date [1]

09/04/2014

Ethics approval number [1]

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

Dr Sharon Henare

Address

Riddet Institute
Massey University
Private Bag 11222
Palmerston North 4442

Country

New Zealand

Phone

+64 6 3569099 ext 84289

Fax

+64 6 3505655

S.J.Henare@massey.ac.nz

Contact person for public queries

Name

Sharon Henare

Address

Riddet Institute
Massey University
Private Bag 11222
Palmerston North 4442

Country

New Zealand

Phone

+64 6 3569099 ext 84289

Fax

+64 6 3505655

S.J.Henare@massey.ac.nz

Contact person for scientific queries

Name

Sharon Henare

Address

Riddet Institute
Massey University
Private Bag 11222
Palmerston North 4442

Country

New Zealand

Phone

+64 6 3569099 ext 84289

Fax

+64 6 3505655

S.J.Henare@massey.ac.nz

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

Source	Title	Year of Publication	DOI
Embase	Iron bioavailability of a casein-based iron fortificant compared with that of ferrous sulfate in whole milk: A randomized trial with a crossover design in adult women.	2019	https://dx.doi.org/10.1093/ajcn/nqz237

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically