NCT07508917

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Fundació Sant Joan de Déu · Academic / Other
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breastfeeding

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	5-MTHF Supplementation	Oral supplementation with 5-MTHF (800 µg) administered daily for 6 weeks during lactation.
OTHER	Placebo	Matching placebo administered daily for 6 weeks during lactation.

Timeline

• Start date: 2026-04-15
• Primary completion: 2026-11-30
• Completion: 2027-02-28
• First posted: 2026-04-02
• Last updated: 2026-04-02

Locations

2 sites across 1 country: Spain