Breast-milk and infant nutrition study

Not Applicable

Recruiting

• Conditions: Folic acid status; Total folate status; Human milk folate concentration; Other nutritional indices (vitamins B6 and B12, choline, betaine, dimethylglycine, methioinine, homocysteine, cysteine, cystathionine, iron, zinc, and selenium); Diet and Nutrition - Other diet and nutrition disorders; Reproductive Health and Childbirth - Breast feeding

• Registration Number: ACTRN12612000656831
• Lead Sponsor: Dr Lisa Houghton

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Infant total whole-blood folate status assessed by isotope dilution-liquid chromatography-tandem mass spectrometry[8 weeks postpartum];Human milk folate-binding protein concentration assessed by ELISA assay[8 weeks postpartum];Infant total serum folate status assessed by isotope dilution-liquid chromatography-tandem mass spectrometry[8 weeks postpartum]

Secondary Outcome Measures

Name	Time	Method
Blood one-carbon metabolites of the mother and infant assessed by isotope dilution-liquid chromatography-tandem mass spectrometry methods[8 weeks postpartum]