BreastfeedingPhase 1/2OCMSNCT07508917
Effects of 5-Methyltetrahydrofolic Acid Supplementation on Maternal Health and One-Carbon Metabolism During Lactation
A Phase 1/2 study testing 5-MTHF Supplementation in people with Breastfeeding, run by Fundació Sant Joan de Déu at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Breastfeeding
- What is being tested?
- 5-MTHF Supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Apr 2026to 28 Feb 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Maternal age between 18 and 42 years
- Gestational age at birth ≥ 37 weeks.
- Exclusive breastfeeding at enrollment.
- Infant age 0-1 months
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites
Hospital Sant Joan de Deu
Barcelona, Barcelona, 08950
Carles Lerin, PhD, (+34) 93 600 97 51, carles.lerin@sjd.es
Hospital Sant Joan de Déu
Barcelona, Barcelona, 08950
Carles Lerin, PhD, Spain ext. 936009751, carles.lerin@sjd.es
Carles Lerin, Spain ext. 601106790, carleslerin@gmail.com
About this study
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
- Being tested
- 5-MTHF Supplementation, Placebo
- Keywords
- 5-Methyltetrahydrofolate (5-MTHF), One-carbon metabolism, Human milk oligosaccharides, Breast milk composition, Betaine, Early-life nutrition, Maternal supplementation, Maternal mental health, 5-MTHF, Gut Microbiome, Metabolomics, Infant Microbiota
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-MTHF SupplementationDietary supplement
Oral supplementation with 5-MTHF (800 µg) administered daily for 6 weeks during lactation.
PlaceboOther
Matching placebo administered daily for 6 weeks during lactation.
| Study group | Role | What they receive |
|---|---|---|
| 5-MTHF Supplementation | Experimental | Dietary Supplement (5-MTHF) Receives: Dietary Supplement: 5-MTHF Supplementation |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 6 weeks
Secondary outcomes (16)
Change in plasma 5-MTHF concentration
Change in maternal plasma 5-MTHF concentration measured with liquid chromatography coupled to mass spectrometry (LC-MS) from Baseline to 6 weeks.
Measured: Baseline, 6 weeks
Change in breast milk one-carbon metabolite concentration
Change in breast milk one-carbon-related metabolites (choline, methionine, SAM, SAH, homocysteine, cystathionine, folic acid, betaine) from Baseline to 6 weeks.
Measured: Baseline, 6 weeks
Change in plasma one-carbon metabolite concentration
Change in plasma one-carbon-related metabolites (choline, methionine, SAM, SAH, homocysteine, cystathionine, folic acid, betaine) from Baseline to 6 weeks.
Measured: Baseline, 6 weeks
Change in Human Milk Oligosaccharide (HMO) concentration
Change in HMO concentrations between Baseline and 6 weeks
Measured: Baseline, 6 weeks
Change in Maternal Plasma Glucose Concentration
Change in maternal blood glucose levels between baseline and 6 weeks.
Measured: Baseline, 6 weeks
Change in Maternal Plasma Glycated Hemoglobin (HbA1c) Concentration
Change in maternal blood glycated hemoglobin (HbA1c) between baseline and 6 weeks.
Measured: Baseline, 6 weeks
Change in Maternal Plasma Insulin Concentration
Change in maternal blood insulin levels between Baseline and 6 weeks.
Measured: Baseline, 6 weeks
Change in Maternal Plasma Triglyceride (TAG) Concentration
Change in maternal blood triglyceride (TAG) levels between baseline and 6 weeks.
Measured: Baseline, 6 weeks
Change in Maternal Blood Total Cholesterol Concentration
Change in maternal blood total Cholesterol levels between baseline and 6 weeks.
Measured: Baseline, 6 weeks
Change in Maternal Blood LDL Cholesterol Concentration
Change in maternal low-density lipoprotein (LDL) cholesterol levels between baseline and 6 weeks.
Measured: Baseline, 6 weeks
Change in Maternal Blood HDL Cholesterol Concentration
Change in maternal high-density lipoprotein (HDL) cholesterol levels between baseline and 6 weeks.
Measured: Baseline, 6 weeks
Change in Maternal Blood Alanine Aminotransferase (ALT) Levels
Change in maternal alanine aminotransferase (ALT) levels between baseline and 6 weeks.
Measured: Baseline, 6 weeks
Change in Maternal Blood Aspartate Aminotransferase (AST) Levels
Change in maternal aspartate aminotransferase (AST) levels between baseline and 6 weeks.
Measured: Baseline, 6 weeks
Change in Maternal Blood Gamma-Glutamyl Transferase (GGT) Levels
Change in maternal gamma-glutamyl transferase (GGT) levels between baseline and 6 weeks.
Measured: Baseline, 6 weeks
Change in Symptom Checklist-90-Revised (SCL-90-R) scale
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.
Measured: Baseline, 3 weeks
Change in infant BMI z-score
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.
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carles Lerin, PhD, Principal investigator, Fundació Sant Joan de Déu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508917
- Sponsor's protocol ID
- PIC-143-25
- Acronym
- OCMS
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 5-Methyltetrahydrofolic Acid Supplementation on Maternal Health and One-Carbon Metabolism During Lactation
- ClinicalTrials.gov ID
- NCT07508917
- Acronym / sponsor ID
- OCMS / PIC-143-25
- Conditions
- Breastfeeding
- Keywords
- 5-Methyltetrahydrofolate (5-MTHF), One-carbon metabolism, Human milk oligosaccharides, Breast milk composition, Betaine, Early-life nutrition, Maternal supplementation, Maternal mental health
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5-MTHF Supplementation | Experimental | Dietary Supplement: 5-MTHF SupplementationDietary Supplement (5-MTHF) |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Maternal age between 18 and 42 years
- Gestational age at birth ≥ 37 weeks.
- Exclusive breastfeeding at enrollment.
- Infant age 0-1 months
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-MTHF SupplementationOral supplementation with 5-MTHF (800 µg) administered daily for 6 weeks during lactation. | Dietary supplement | 5-MTHF Supplementation |
| PlaceboMatching placebo administered daily for 6 weeks during lactation. | Other | Placebo |
Primary outcome
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.
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.
16 secondary outcomes
Change in plasma 5-MTHF concentration
Time frame: Baseline, 6 weeks
Change in breast milk one-carbon metabolite concentration
Time frame: Baseline, 6 weeks
Change in plasma one-carbon metabolite concentration
Time frame: Baseline, 6 weeks
Change in Human Milk Oligosaccharide (HMO) concentration
Time frame: Baseline, 6 weeks
Change in Maternal Plasma Glucose Concentration
Time frame: Baseline, 6 weeks
Change in Maternal Plasma Glycated Hemoglobin (HbA1c) Concentration
Time frame: Baseline, 6 weeks
Change in Maternal Plasma Insulin Concentration
Time frame: Baseline, 6 weeks
Change in Maternal Plasma Triglyceride (TAG) Concentration
Time frame: Baseline, 6 weeks
Change in Maternal Blood Total Cholesterol Concentration
Time frame: Baseline, 6 weeks
Change in Maternal Blood LDL Cholesterol Concentration
Time frame: Baseline, 6 weeks
Change in Maternal Blood HDL Cholesterol Concentration
Time frame: Baseline, 6 weeks
Change in Maternal Blood Alanine Aminotransferase (ALT) Levels
Time frame: Baseline, 6 weeks
Change in Maternal Blood Aspartate Aminotransferase (AST) Levels
Time frame: Baseline, 6 weeks
Change in Maternal Blood Gamma-Glutamyl Transferase (GGT) Levels
Time frame: Baseline, 6 weeks
Change in Symptom Checklist-90-Revised (SCL-90-R) scale
Time frame: Baseline, 3 weeks
Change in infant BMI z-score
Time frame: Baseline, 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carles Lerin, PhD principal investigator
Fundació Sant Joan de Déu
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 5-MTHF Supplementation in people with Breastfeeding, run by Fundació Sant Joan de Déu at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carles Lerin, PhD ((+34) 93 600 97 51, carles.lerin@sjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: Baseline, 6 weeks, 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.