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

Phase 2Not Yet RecruitingNCT07508917

Fundació Sant Joan de Déu36 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Breastfeeding

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 42 Years

Medical Language ↔ Plain English

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

Locations (2)

Hospital Sant Joan de Deu

Barcelona, Barcelona, Spain

Hospital Sant Joan de Déu

Barcelona, Barcelona, Spain

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline, 6 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, 6 weeks

Change in Human Milk Oligosaccharide (HMO) concentration

Change in HMO concentrations between Baseline and 6 weeks

Time frame: Baseline, 6 weeks

Change in Maternal Plasma Glucose Concentration

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

Time frame: Baseline, 6 weeks

Change in Maternal Plasma Glycated Hemoglobin (HbA1c) Concentration

Change in maternal blood glycated hemoglobin (HbA1c) between baseline and 6 weeks.

Time frame: Baseline, 6 weeks

Change in Maternal Plasma Insulin Concentration

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

Time frame: Baseline, 6 weeks

Change in Maternal Plasma Triglyceride (TAG) Concentration

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

Time frame: Baseline, 6 weeks

Change in Maternal Blood Total Cholesterol Concentration

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

Time frame: Baseline, 6 weeks

Change in Maternal Blood LDL Cholesterol Concentration

Change in maternal low-density lipoprotein (LDL) cholesterol levels between baseline and 6 weeks.

Time frame: Baseline, 6 weeks

Change in Maternal Blood HDL Cholesterol Concentration

Change in maternal high-density lipoprotein (HDL) cholesterol levels between baseline and 6 weeks.

Time frame: Baseline, 6 weeks

Change in Maternal Blood Alanine Aminotransferase (ALT) Levels

Change in maternal alanine aminotransferase (ALT) levels between baseline and 6 weeks.

Time frame: Baseline, 6 weeks

Change in Maternal Blood Aspartate Aminotransferase (AST) Levels

Change in maternal aspartate aminotransferase (AST) levels between baseline and 6 weeks.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, 6 weeks

Central Contacts

Carles Lerin, PhD

CONTACT

(+34) 93 600 97 51 carles.lerin@sjd.es

Marta Ramon Krauel, MD PhD

CONTACT

(+34) 93 280 40 00 marta.ramon@sjd.es