Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000463976
Ethics application status
Approved
Date submitted
2/05/2011
Date registered
5/05/2011
Date last updated
6/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Folate status of women of childbearing age in Dunedin and Wellington, New Zealand
Scientific title
A cross-sectional survey of women between the ages of 18 and 44 years to determine their serum and red blood cell folate concentrations.
Secondary ID [1] 260078 0
Nil
Universal Trial Number (UTN)
U1111-1121-0880
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood folate status 265752 0
Consumption of folic acid fortified foods. 265789 0
Condition category
Condition code
Public Health 265897 265897 0 0
Epidemiology
Diet and Nutrition 265898 265898 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Fasting serum and red blood cell folate concentrations at one point in time. Frequency of consumption of folic acid fortified foods.
Intervention code [1] 264495 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266659 0
Serum and red blood cell folate concentrations as measured by a microbiological assay.
Timepoint [1] 266659 0
One timepoint.
Secondary outcome [1] 276152 0
Frequency of consumption of folic acid fortified foods as assessed by a telephone interview.
Timepoint [1] 276152 0
Asked at one point in time about the consumption of folic acid fortified foods. This occurs within 2 weeks of the blood test.

Eligibility
Key inclusion criteria
Females between the ages of 18 and 44 years.
Minimum age
18 Years
Maximum age
44 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
nil

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 3435 0
New Zealand
State/province [1] 3435 0
Dunedin
Country [2] 3436 0
New Zealand
State/province [2] 3436 0
Wellington

Funding & Sponsors
Funding source category [1] 264974 0
Government body
Name [1] 264974 0
Ministry of Agriculture and Forestry
Country [1] 264974 0
New Zealand
Primary sponsor type
Individual
Name
Professor Murray Skeaff
Address
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 264064 0
Individual
Name [1] 264064 0
Kathryn Bradbury
Address [1] 264064 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country [1] 264064 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266933 0
University of Otago Human Ethics Committee
Ethics committee address [1] 266933 0
Academic Services
University of Otago
PO Box 56
Dunedin 9054
Ethics committee country [1] 266933 0
New Zealand
Date submitted for ethics approval [1] 266933 0
Approval date [1] 266933 0
24/01/2011
Ethics approval number [1] 266933 0
F10/015

Summary
Brief summary
In August 2009 the government announced that mandatory fortification of bread with folic acid - due to be implemented in September 2009 - would be delayed until May 2012. In the interim, the bread manufacturers agreed to voluntarily fortify approximately 30% of their breads with folic acid from April 2010. The proposed project is a cross-sectional survey of women of childbearing age from two New Zealand centers - Dunedin and Wellington - to be undertaken in 2011. The purpose of the research is to determine blood folate levels of women following the adoption of the new voluntary fortification programme.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32547 0
Address 32547 0
Country 32547 0
Phone 32547 0
Fax 32547 0
Email 32547 0
Contact person for public queries
Name 15794 0
Kathryn Bradbury
Address 15794 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 15794 0
New Zealand
Phone 15794 0
+64 3 479 5673
Fax 15794 0
+64 3 479 7958
Email 15794 0
kathryn.bradbury@otago.ac.nz
Contact person for scientific queries
Name 6722 0
Professor Murray Skeaff
Address 6722 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 6722 0
New Zealand
Phone 6722 0
+64 3 479 7688
Fax 6722 0
+64 3 479 7958
Email 6722 0
murray.skeaff@otago.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
SourceTitleYear of PublicationDOI
Dimensions AISerum and erythrocyte folate status of New Zealand women of childbearing age following a countrywide voluntary programme by the baking industry to fortify bread with folic acid2016https://doi.org/10.1017/s136898001600121x
N.B. These documents automatically identified may not have been verified by the study sponsor.