Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12611000446965
Ethics application status
Approved
Date submitted
2/05/2011
Date registered
2/05/2011
Date last updated
2/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of choice of feeding on DNA damage in 3-6 month old infants – a pilot study
Scientific title
Impact of choice of feeding on DNA damage in 3-6 month old infants – a pilot study
Secondary ID [1] 260089 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diet and Nutrition .The aim of the study is to determine whether the choice of how an infant is fed affects their DNA and folate in the body. 265773 0
Condition category
Condition code
Diet and Nutrition 252289 252289 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
The collection of a heel prick blood sample from infants when they at 3months of age and then when they are at 6 months of age.Completion of questionnaires relating to health and lifestyle of both the mother and child which includes the feeding regime of the infant will be done twice,when the child is 3 months of age and at 6 months of age.
Intervention code [1] 264510 0
Lifestyle
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266683 0
To determine whether the choice of how an infant is fed affects their DNA and folate in the body.This will be done by collecting the heel prick blood sample from the infants and collecting a feeding and food questionnaire from the mother.The validated Cancer Council of Victoria Food frequency questionnaire will be used.
Timepoint [1] 266683 0
The mother and infant will attend one visit when the child is 3 months of age and one visit when they are 6 months of age.
Secondary outcome [1] 276171 0
Nil
Timepoint [1] 276171 0
Nil

Eligibility
Key inclusion criteria
Healthy mothers and their infants,born at term or at least a minimum of 38 weeks gestation.
Minimum age
3 Months
Maximum age
6 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Infants of multiple parity,mothers who cannot understand the study protocol and are unable to give appropriate consent to all stages of the protocol and attend the clinic when the infant is approximately 3 months and 6 months of age.Infants who have been introduced to solid foods prior to 3months of age.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264994 0
Other Collaborative groups
Name [1] 264994 0
Cancer Council of Australia
Country [1] 264994 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Cancer Council of Australia
Address
202 Greenhill Rd
Eastwood SA 5063
Country
Australia
Secondary sponsor category [1] 264084 0
None
Name [1] 264084 0
Nil
Address [1] 264084 0
Nil
Country [1] 264084 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 30438 0
Address 30438 0
Country 30438 0
Phone 30438 0
Fax 30438 0
Email 30438 0
Contact person for public queries
Name 13685 0
Dr Nathan O'Callaghan
Address 13685 0
Commonwealth Scientific and Industrial Research Organisation
Kintore Ave
Adelaide SA 5000
Country 13685 0
Australia
Phone 13685 0
+61 08 83038867
Fax 13685 0
Email 13685 0
Nathan.o'callaghan@csiro.au
Contact person for scientific queries
Name 4613 0
Dr Nathan O'Callaghan
Address 4613 0
Commonwealth Scientific and Industrial Research Organisation
Kintore Ave
Adelaide SA 5000
Country 4613 0
Australia
Phone 4613 0
+61 08 83038867
Fax 4613 0
Email 4613 0
Nathan.o'callaghan@csiro.au

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.