Effects of 5-Methyltetrahydrofolic Acid Supplementation on Maternal Health and One-Carbon Metabolism During Lactation

Condition(s) studied

Investigational drug(s) / intervention(s)

5-MTHF Supplementation: Oral supplementation with 5-MTHF (800 µg) administered daily for 6 weeks during lactation.

Placebo: Matching placebo administered daily for 6 weeks during lactation.

Study summary

This double-blind, randomized, placebo-controlled parallel trial evaluates the effects of maternal 5-methyltetrahydrofolate (5-MTHF) supplementation during breastfeeding. Thirty-six lactating mother-infant dyads will be randomized (1:1) to receive 5-MTHF or placebo for 6 weeks, stratified by infant sex and mode of delivery. Tolerability and adverse events will be monitored.

Pre- and post-intervention assessments include breast milk one-carbon metabolites and oligosaccharides; maternal plasma one-carbon metabolites and metabolic health markers. Maternal mental health will be evaluated using the SCL-90-R questionnaire. A follow-up visit at 4 months will reassess infant anthropometry and microbiome outcomes.

Eligibility

Primary outcome measure(s)

• Incidence of Adverse Events — Baseline, 6 weeks, 4 months
  Treatment safety and tolerability will be evaluated by assessing differences in the incidence of potential adverse events between groups, focusing on gastrointestinal symptoms.
• Change in breast milk 5-MTHF concentration — Baseline, 6 weeks
  Change in breast milk 5-MTHF concentration measured with liquid chromatography coupled to mass spectrometry (LC-MS) from Baseline to 6 weeks.

Trial sites (2)

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