RecruitingACTRN12612000656831

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.


Sponsor

Dr Lisa Houghton

Enrollment

70 participants

Start Date

Aug 7, 2012

Study Type

Observational

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 7 WeekssMax Age: 9 Weekss

Plain Language Summary

Simplified for easier understanding

This study examines whether high folic acid intake by breastfeeding mothers affects a special protein in breast milk that helps babies absorb folate (a B vitamin). Folate is essential for healthy development, but researchers want to understand how much of it reaches babies through breast milk and whether taking a lot of folic acid changes how the milk delivers it. You may be eligible if: - You are a breastfeeding mother aged 18 to 42 years - You have a healthy baby born between 37 and 42 weeks of pregnancy - Your baby is between 7 and 9 weeks old - You are exclusively breastfeeding You may NOT be eligible if: - You had a high-risk pregnancy (eclampsia or HELLP syndrome) - You have diabetes, heart disease, kidney disease, inflammatory bowel disease, or celiac disease - You have had gastric bypass surgery - You take certain medications (including valproic acid, methotrexate, metformin, or some antibiotics) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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-bindin

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.


Locations(1)

Dunedin, New Zealand

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ACTRN12612000656831