Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000656831
Ethics application status
Approved
Date submitted
18/06/2012
Date registered
19/06/2012
Date last updated
17/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Breast-milk and infant nutrition study
Scientific title
An observational, cross-sectional study on the effect of maternal blood folic acid and total folate status on human milk folate-binding protein concentration and infant folate status at 8 weeks postpartum.
Secondary ID [1] 280693 0
Nil
Universal Trial Number (UTN)
U1111-1131-9116
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Folic acid status 286721 0
Total folate status 286722 0
Human milk folate concentration 286723 0
Other nutritional indices (vitamins B6 and B12, choline, betaine, dimethylglycine, methioinine, homocysteine, cysteine, cystathionine, iron, zinc, and selenium) 286724 0
Condition category
Condition code
Diet and Nutrition 287022 287022 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 287036 287036 0 0
Breast feeding

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The primary exposure of interest is the blood folic acid concentration and blood folate status of the mother. The study aims to observe the effect of maternal blood folate status on milk folate-binding protein concentration and on infant blood folate status. Blood folic acid status and blood total folate status of the mother are assessed at 8 weeks postpartum (the folate status of the mother will be conditional on the previous folate and folic acid intake, most likely over the course of the pregnancy as steady state concentrations are only reached after 40 or more weeks). Folate-binding protein concentration and total folate in breast-milk at 8 weeks postpartum is also measured as an exposure variable in relation to infant folate status.
Intervention code [1] 285104 0
Not applicable
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287361 0
Human milk folate-binding protein concentration assessed by ELISA assay
Timepoint [1] 287361 0
8 weeks postpartum
Primary outcome [2] 287362 0
Infant total serum folate status assessed by isotope dilution-liquid chromatography-tandem mass spectrometry
Timepoint [2] 287362 0
8 weeks postpartum
Primary outcome [3] 287363 0
Infant total whole-blood folate status assessed by isotope dilution-liquid chromatography-tandem mass spectrometry
Timepoint [3] 287363 0
8 weeks postpartum
Secondary outcome [1] 297992 0
Blood one-carbon metabolites of the mother and infant assessed by isotope dilution-liquid chromatography-tandem mass spectrometry methods
Timepoint [1] 297992 0
8 weeks postpartum

Eligibility
Key inclusion criteria
Maternal age 18 to 42 years
Healthy singleton infant born between 37 to 42 weeks gestation inclusive
Exclusive breastfeeding
Minimum age
7 Weeks
Maximum age
9 Weeks
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
High risk pregnancy (eclampsia or HELLP syndrome)
Diabetes
Cardiac disease
Renal disease
Inflammatory bowel syndrome
Coeliac Disease
Gastric bypass surgery
Medications (valproic acid, carbamazepine, phenobarbital, primidone, methotrexate, fluorouracil, premetrexed, pyrimethamine, trimethoprim, thiazide diuretics, sulfasalazine, pancreatin, cholestryramine, colestipol, metformin)

Study design
Purpose
Duration
Cross-sectional
Selection
Convenience sample
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 4368 0
New Zealand
State/province [1] 4368 0
Dunedin

Funding & Sponsors
Funding source category [1] 285461 0
University
Name [1] 285461 0
University of Otago Research Grant
Country [1] 285461 0
New Zealand
Primary sponsor type
Individual
Name
Dr Lisa Houghton
Address
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 284314 0
None
Name [1] 284314 0
Address [1] 284314 0
Country [1] 284314 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287476 0
University of Otago Human Ethics Committee
Ethics committee address [1] 287476 0
PO Box 56
University of Otago
Dunedin 9054
Ethics committee country [1] 287476 0
New Zealand
Date submitted for ethics approval [1] 287476 0
05/04/2012
Approval date [1] 287476 0
20/04/2012
Ethics approval number [1] 287476 0
1/12/0086

Summary
Brief summary
The aim of the study is to measure the amount of folate-binding protein in human milk and to determine if it is down-regulated by high folic acid consumption using maternal blood folic acid and total folate status as biomarkers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34329 0
Address 34329 0
Country 34329 0
Phone 34329 0
Fax 34329 0
Email 34329 0
Contact person for public queries
Name 17576 0
Rosemary Stamm
Address 17576 0
Human Nutrition Department
PO Box 56
University of Otago
Dunedin 9054
Country 17576 0
New Zealand
Phone 17576 0
+64,3,4797948
Fax 17576 0
Email 17576 0
[email protected]
Contact person for scientific queries
Name 8504 0
Dr Lisa Houghton
Address 8504 0
Human Nutrition Department
PO Box 56
University of Otago
Dunedin 9054
Country 8504 0
New Zealand
Phone 8504 0
+64,3,4797294
Fax 8504 0
Email 8504 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
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Documents added automatically
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