Could a simple vitamin boost breast milk quality?
NCT ID NCT07508917
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a daily 5-MTHF supplement (a form of folate) is safe and beneficial for breastfeeding mothers and their babies. Thirty-six mother-infant pairs will receive either the supplement or a placebo for six weeks. Researchers will measure changes in breast milk composition, maternal health markers, and infant growth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 5-Methyltetrahydrofolic acid (5-MTHF) dietary supplement
- What this could lead to
- If successful, this could show that 5-MTHF supplements are safe and beneficial for breastfeeding mothers, potentially improving maternal health and infant nutrition.
- What could go wrong
- This is an early-phase trial with only 36 participants, so results may not apply widely. The study focuses on biomarkers and safety, not on curing a disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 42 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Sant Joan de Deu
Barcelona, Barcelona, 08950, Spain
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Hospital Sant Joan de Déu
Barcelona, Barcelona, 08950, Spain
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