Pharmacokinetic Assessment of Betaine Supplementation in Lactating Mothers
NCT ID: NCT07243678
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
10 participants
INTERVENTIONAL
2025-12-31
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Betaine Supplementation (Sequential Low and High Dose)
Participants will receive oral betaine supplementation at a low dose (400 milligrams/day) for one week, followed by a high dose (1.5 grams/day) for one additional week. Milk samples will be collected at baseline and at multiple time points to evaluate betaine dynamics, accumulation, and associated metabolic changes.
Betaine supplement
Oral betaine supplementation will be administered to lactating women. Participants will receive a dose of 400 milligrams/day for 1 week, followed by 1.5 grams/day for an additional week.
Interventions
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Betaine supplement
Oral betaine supplementation will be administered to lactating women. Participants will receive a dose of 400 milligrams/day for 1 week, followed by 1.5 grams/day for an additional week.
Eligibility Criteria
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Inclusion Criteria
* Infant age between 2 and 5 months
Exclusion Criteria
* Infant weight at recruitment \< -1 standard deviations (SD)
* Cystathionine Beta-Synthase (CBS) deficiency (inherited disease)
18 Years
42 Years
FEMALE
Yes
Sponsors
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Fundació Sant Joan de Déu
OTHER
Responsible Party
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Locations
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Hospital Sant Joan de Deu
Barcelona, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PIC-142-25
Identifier Type: OTHER
Identifier Source: secondary_id
PIC-142-25
Identifier Type: -
Identifier Source: org_study_id
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