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

March 27, 2026 updated by: Fundació Sant Joan de Déu

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Marta Ramon Krauel, MD PhD
  • Phone Number: Ext. 71263 (+34) 93 280 40 00
  • Email: marta.ramon@sjd.es

Study Locations

  • Spain
    • Barcelona
      • Barcelona, Barcelona, Spain, 08950

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Other: Placebo
Matching placebo administered daily for 6 weeks during lactation.
Experimental: 5-MTHF Supplementation
Dietary Supplement (5-MTHF)
Dietary supplement: 5-MTHF Supplementation
Oral supplementation with 5-MTHF (800 µg) administered daily for 6 weeks during lactation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events
Time Frame: 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.
Baseline, 6 weeks, 4 months
Change in breast milk 5-MTHF concentration
Time Frame: 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.
Baseline, 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in plasma 5-MTHF concentration
Time Frame: Baseline, 6 weeks
Change in maternal plasma 5-MTHF concentration measured with liquid chromatography coupled to mass spectrometry (LC-MS) from Baseline to 6 weeks.
Baseline, 6 weeks
Change in breast milk one-carbon metabolite concentration
Time Frame: Baseline, 6 weeks
Change in breast milk one-carbon-related metabolites (choline, methionine, SAM, SAH, homocysteine, cystathionine, folic acid, betaine) from Baseline to 6 weeks.
Baseline, 6 weeks
Change in plasma one-carbon metabolite concentration
Time Frame: Baseline, 6 weeks
Change in plasma one-carbon-related metabolites (choline, methionine, SAM, SAH, homocysteine, cystathionine, folic acid, betaine) from Baseline to 6 weeks.
Baseline, 6 weeks
Change in Human Milk Oligosaccharide (HMO) concentration
Time Frame: Baseline, 6 weeks
Change in HMO concentrations between Baseline and 6 weeks
Baseline, 6 weeks
Change in Maternal Plasma Glucose Concentration
Time Frame: Baseline, 6 weeks
Change in maternal blood glucose levels between baseline and 6 weeks.
Baseline, 6 weeks
Change in Maternal Plasma Glycated Hemoglobin (HbA1c) Concentration
Time Frame: Baseline, 6 weeks
Change in maternal blood glycated hemoglobin (HbA1c) between baseline and 6 weeks.
Baseline, 6 weeks
Change in Maternal Plasma Insulin Concentration
Time Frame: Baseline, 6 weeks
Change in maternal blood insulin levels between Baseline and 6 weeks.
Baseline, 6 weeks
Change in Maternal Plasma Triglyceride (TAG) Concentration
Time Frame: Baseline, 6 weeks
Change in maternal blood triglyceride (TAG) levels between baseline and 6 weeks.
Baseline, 6 weeks
Change in Maternal Blood Total Cholesterol Concentration
Time Frame: Baseline, 6 weeks
Change in maternal blood total Cholesterol levels between baseline and 6 weeks.
Baseline, 6 weeks
Change in Maternal Blood LDL Cholesterol Concentration
Time Frame: Baseline, 6 weeks
Change in maternal low-density lipoprotein (LDL) cholesterol levels between baseline and 6 weeks.
Baseline, 6 weeks
Change in Maternal Blood HDL Cholesterol Concentration
Time Frame: Baseline, 6 weeks
Change in maternal high-density lipoprotein (HDL) cholesterol levels between baseline and 6 weeks.
Baseline, 6 weeks
Change in Maternal Blood Alanine Aminotransferase (ALT) Levels
Time Frame: Baseline, 6 weeks
Change in maternal alanine aminotransferase (ALT) levels between baseline and 6 weeks.
Baseline, 6 weeks
Change in Maternal Blood Aspartate Aminotransferase (AST) Levels
Time Frame: Baseline, 6 weeks
Change in maternal aspartate aminotransferase (AST) levels between baseline and 6 weeks.
Baseline, 6 weeks
Change in Maternal Blood Gamma-Glutamyl Transferase (GGT) Levels
Time Frame: Baseline, 6 weeks
Change in maternal gamma-glutamyl transferase (GGT) levels between baseline and 6 weeks.
Baseline, 6 weeks
Change in Symptom Checklist-90-Revised (SCL-90-R) scale
Time Frame: Baseline, 3 weeks
The SCL-90-R is a 90-item self-report questionnaire assessing psychological symptoms over the past week, with a range of 0-90 across 9 dimenions: Somatization, Obsessive-compulsive, Interpersonal sensitivity, Depression, Anxiety, Hostility, Phobic anxiety, Paranoid ideation, Psychoticism. Higher scores indicate worse outcome.
Baseline, 3 weeks
Change in infant BMI z-score
Time Frame: Baseline, 6 weeks
We will measure infant body weight, length, and head circumference to calculate BMI z-scores according to WHO growth standards, and changes between baseline, 6 weeks and 4 months will be assessed.
Baseline, 6 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal and infant gut microbiome composition
Time Frame: Baseline, 6 weeks
Bacterial DNA will be isolated from infant and maternal fecal samples and sequenced to obtain microbiome composition.
Baseline, 6 weeks
Maternal plasma and breast milk metabolomic profile
Time Frame: Baselina, 6 weeks
The metabolomic profile will be obtained with the Biocrates Quant 1000 kit from plasma and breast milk samples.
Baselina, 6 weeks
Milk imprinted protein levels
Time Frame: Baseline, 6 weeks
Imprinted proteins in human milk samples will be analyzed by ELISA.
Baseline, 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundació Sant Joan de Déu

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carles Lerin, PhD, Fundació Sant Joan de Déu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PIC-143-25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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