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NCT Number: NCT07508917

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

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.

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital Sant Joan de Deu, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5-MTHF Supplementation

Dietary Supplement

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

Placebo

Other

Matching placebo administered daily for 6 weeks during lactation.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Change in Human Milk Oligosaccharide (HMO) concentration

    Time frame: Baseline, 6 weeks

    Change in HMO concentrations between Baseline and 6 weeks

  5. Change in Maternal Plasma Glucose Concentration

    Time frame: Baseline, 6 weeks

    Change in maternal blood glucose levels between baseline and 6 weeks.

  6. 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.

  7. Change in Maternal Plasma Insulin Concentration

    Time frame: Baseline, 6 weeks

    Change in maternal blood insulin levels between Baseline and 6 weeks.

  8. Change in Maternal Plasma Triglyceride (TAG) Concentration

    Time frame: Baseline, 6 weeks

    Change in maternal blood triglyceride (TAG) levels between baseline and 6 weeks.

  9. Change in Maternal Blood Total Cholesterol Concentration

    Time frame: Baseline, 6 weeks

    Change in maternal blood total Cholesterol levels between baseline and 6 weeks.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

Other outcomes

  1. 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.

  2. 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.

  3. Milk imprinted protein levels

    Time frame: Baseline, 6 weeks

    Imprinted proteins in human milk samples will be analyzed by ELISA.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Registry information

Acronym: OCMS

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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