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ClinicalTrials.gov ID

NCT07508917

Lead Sponsor

Fundació Sant Joan de DéuOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 1Phase 2

Enrollment

36Estimated

Last Update Posted

Apr 2, 2026Actual

Start Date

Apr 15, 2026Estimated

Primary Completion Date

Nov 30, 2026Estimated

Completion Date

Feb 28, 2027Estimated

Official Title

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

Brief 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.

• Breastfeeding

• 5-MTHF Supplementation
• Placebo

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Maternal age between 18 and 42 years
• Gestational age at birth ≥ 37 weeks.
• Exclusive breastfeeding at enrollment.
• Infant age 0-1 months

Exclusion Criteria:

• Multiple pregnancy
• Presence of disease or malformations in the infant.
• Weight-Standard Deviation Score < -1 at enrollment.
• Use of folate-containing multivitamin supplements during breastfeeding

Primary Purpose

Basic Science

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

Fundació Sant Joan de DéuOTHER

carles.lerin@sjd.esSpain ext. 936009751