NCT07508917

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
7mo left

Started Apr 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
Apr 2026Feb 2027

First Submitted

Initial submission to the registry

March 19, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

March 19, 2026

Last Update Submit

March 27, 2026

Conditions

Breastfeeding

Keywords

5-Methyltetrahydrofolate (5-MTHF)One-carbon metabolismHuman milk oligosaccharidesBreast milk compositionBetaineEarly-life nutritionMaternal supplementationMaternal mental health5-MTHFGut MicrobiomeMetabolomicsInfant Microbiota

Outcome Measures

Primary Outcomes (2)

  • Incidence of Adverse Events

    Treatment safety and tolerability will be evaluated by assessing differences in the incidence of potential adverse events between groups, focusing on gastrointestinal symptoms.

    Baseline, 6 weeks, 4 months

  • Change in breast milk 5-MTHF concentration

    Change in breast milk 5-MTHF concentration measured with liquid chromatography coupled to mass spectrometry (LC-MS) from Baseline to 6 weeks.

    Baseline, 6 weeks

Secondary Outcomes (16)

  • Change in plasma 5-MTHF concentration

    Baseline, 6 weeks

  • Change in breast milk one-carbon metabolite concentration

    Baseline, 6 weeks

  • Change in plasma one-carbon metabolite concentration

    Baseline, 6 weeks

  • Change in Human Milk Oligosaccharide (HMO) concentration

    Baseline, 6 weeks

  • Change in Maternal Plasma Glucose Concentration

    Baseline, 6 weeks

  • +11 more secondary outcomes

Other Outcomes (3)

  • Maternal and infant gut microbiome composition

    Baseline, 6 weeks

  • Maternal plasma and breast milk metabolomic profile

    Baselina, 6 weeks

  • Milk imprinted protein levels

    Baseline, 6 weeks

Study Arms (2)

5-MTHF Supplementation

EXPERIMENTAL

Dietary Supplement (5-MTHF)

Dietary Supplement: 5-MTHF Supplementation

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

5-MTHF SupplementationDIETARY_SUPPLEMENT

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

5-MTHF Supplementation
PlaceboOTHER

Matching placebo administered daily for 6 weeks during lactation.

Placebo

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Sant Joan de Deu

Barcelona, Barcelona, 08950, Spain

Location

Hospital Sant Joan de Déu

Barcelona, Barcelona, 08950, Spain

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Carles Lerin, PhD

    Fundació Sant Joan de Déu

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carles Lerin, PhD

CONTACT

(+34) 93 600 97 51carles.lerin@sjd.es

Marta Ramon Krauel, MD PhD

CONTACT

(+34) 93 280 40 00marta.ramon@sjd.es

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2026

First Posted

April 2, 2026

Study Start

April 15, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

April 2, 2026

Record last verified: 2026-03

Locations

ES(2)