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Breast-milk and infant nutrition study

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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12612000656831
Enrollment
70
Registered
2012-06-19
Start date
2012-08-07
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 preg

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.

Sponsors

Dr Lisa Houghton
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
7 Weeks to 9 Weeks
Healthy volunteers
Yes

Inclusion criteria

Maternal age 18 to 42 years Healthy singleton infant born between 37 to 42 weeks gestation inclusive Exclusive breastfeeding

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)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026