Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000360314
Ethics application status
Approved
Date submitted
9/07/2008
Date registered
25/07/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An investigation of the effect of an iron fortified breakfast cereal and kiwifruit on iron status in young women with depleted iron stores
Scientific title
The effect of a 16 week intervention of an iron fortified breakfast cereal and kiwifruit compared with an iron fortified breakfast cereal and a banana on iron status in young women with depleted iron stores
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron deficiency 3436 0
Condition category
Condition code
Diet and Nutrition 3590 3590 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Iron fortified breakfast cereal (15mg iron per serving) and 2 Zespri Gold kiwifruit (high vitamin C) eaten every day for breakfast for 16 weeks
Intervention code [1] 3169 0
Treatment: Other
Comparator / control treatment
Iron fortified breakfast cereal (15mg iron per serving) and a banana (low vitamin C) eaten every day for breakfast for 16 weeks
Control group
Active

Outcomes
Primary outcome [1] 4491 0
Iron status as measured by serum ferritin, haemoglobin and tranferrin receptor
Timepoint [1] 4491 0
Baseline and 16 weeks
Secondary outcome [1] 7499 0
Antioxidant status measured by blood analysis
Timepoint [1] 7499 0
Baseline and 16 weeks
Secondary outcome [2] 7596 0
Folate status measured by blood analysis
Timepoint [2] 7596 0
Baseline and 16 weeks
Secondary outcome [3] 7599 0
Lutein status measured by blood analysis
Timepoint [3] 7599 0
Baseline and 16 weeks

Eligibility
Key inclusion criteria
Females with a serum ferritin of <25ug and a haemoglobin >115g/L
Minimum age
18 Years
Maximum age
44 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy, breastfeeding or planning to become pregnant; health problems likely to affect iron status; allergies or intolerances to kiwifruit, bananas, milk products, or any of the components in breakfast cereal; consumption of iron, vitamin C and calcium supplements

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 1037 0
New Zealand
State/province [1] 1037 0

Funding & Sponsors
Funding source category [1] 3570 0
Commercial sector/Industry
Name [1] 3570 0
Zespri International Limited
Country [1] 3570 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
IFNHH, B22, Old Albany Highway, Massey University, Albany, Auckland
Country
New Zealand
Secondary sponsor category [1] 3211 0
None
Name [1] 3211 0
Address [1] 3211 0
Country [1] 3211 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5611 0
Massey University Human Ethics Committee - Southern A
Ethics committee address [1] 5611 0
Office of the Assistant of the VC, Massey University, Turitea Campus, Private Bag 11222, Palmerston North
Ethics committee country [1] 5611 0
New Zealand
Date submitted for ethics approval [1] 5611 0
Approval date [1] 5611 0
03/06/2008
Ethics approval number [1] 5611 0
08/20

Summary
Brief summary
Iron deficiency is relatively common in young women. Dietary intervention is recommended as the first treatment for mild iron deficiency. Dietary intervention can include a diet high in iron and also eating foods that enhance iron absorption such as foods containing vitamin C and carotenoids. Iron absoriton from a breakfast cereal which is fortified with iron is likely to be enhanced if consumed with kiwifruit as kiwifruit is a rich source of vitamin C and carotenoids. The aim of this study is to investigate whether consuming kiwifruit with a breakfast cereal fortified with iron improves iron status in iron deficient women, compared with the consumption of an iron fortified cereal and a banana (which is low in vitamin C and carotenoids).
Trial website
kiwistudy.massey.ac.nz
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28737 0
Address 28737 0
Country 28737 0
Phone 28737 0
Fax 28737 0
Email 28737 0
Contact person for public queries
Name 11894 0
Kathryn Beck
Address 11894 0
IFNHH, Building 22, Old Albany Highway, Massey University, Albany, Auckland
Country 11894 0
New Zealand
Phone 11894 0
(09) 443 9649
Fax 11894 0
Email 11894 0
[email protected]
Contact person for scientific queries
Name 2822 0
Kathryn Beck
Address 2822 0
IFNHH, Building 22, Old Albany Highway, Massey University, Albany, Auckland
Country 2822 0
New Zealand
Phone 2822 0
(09) 443 9649
Fax 2822 0
Email 2822 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.