Effects of 5-Methyltetrahydrofolic Acid Supplementation on Maternal Health and One-Carbon Metabolism During Lactation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 5-MTHF Supplementation, Placebo.
- Who it may be relevant to
- Registry conditions: Breastfeeding. Basic parameters: 18 years — 42 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Dietary supplement 5-MTHF Supplementation
Oral supplementation with 5-MTHF (800 µg) administered daily for 6 weeks during lactation. - Other Placebo
Matching placebo administered daily for 6 weeks during lactation.
Primary outcome measures
- Incidence of Adverse Events [Time frame: Baseline, 6 weeks, 4 months]
- Change in breast milk 5-MTHF concentration [Time frame: Baseline, 6 weeks]
Secondary outcome measures (12)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Basic science
Study locations
Spain · 2 centers
- Hospital Sant Joan de Deu — Barcelona
- Hospital Sant Joan de Déu — Barcelona
Identifiers
NCT: NCT07508917 · PIC-143-25