None
Conditions
Interventions
Early pregnancy group:Start taking folic acid supplements (0.4 mg daily) when preparing for pregnancy, continuing until 12 completed weeks of gestation
or, if supplementation is initiated for the first time during early pregnancy (gestational age <14 weeks), take 0.4 mg daily and maintain oral intake for 12 consecutive weeks.
Second trimester group:If folic acid supplementation is initiated for the first time during the second trimester (gestational age 14 weeks to 27 weeks +6 days), take 0.4 mg daily and maintain oral sup
Third trimester group:For cases where folic acid supplementation is maintained throughout the entire pregnancy, take 0.4 mg daily via oral administration for 12 consecutive weeks, followed by a reduce
Control group:None
Sponsors
The First Affiliated Hospital of Heilongjiang University of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Female aged 20 to 45 years (inclusive); 2. Confirmed pregnancy or actively planning to conceive; 3. Voluntary participation with written informed consent. All criteria must be met simultaneously.*
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. History of folic acid allergy or hypersensitivity to any component of the supplementation; 2. Current or planned use of medications or supplements known to interfere with folic acid absorption or metabolism (e.g. anticonvulsants methotrexate); 3. Severe cardiovascular hepatic or renal dysfunction or other major systemic diseases** (e.g. ALT/AST >2×ULN eGFR 906 nmol/L** (precluding supplementation efficacy assessment); 8. Conditions deemed by investigators to reduce enrollment feasibility** (e.g. high risk of loss to follow-up due to relocation) **or inability to provide informed consent (cognitive/behavioral impairments). Exclusionary if any single criterion is met.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma Biomarkers: 5-methyltetrahydrofolate (5-MTHF) folate homocysteine vitamins B2 (riboflavin) B3 (niacin) B6 (pyridoxine) and methylmalonic acid (MMA a reverse biomarker of vitamin B12). ;RBC Biomarkers: 5-MTHF folate vitamin B12 B2 B3 and B6. ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pregnancy complications: Gestational hypertension; gestational diabetes mellitus (GDM); preeclampsia (PE); anemia; small for gestational age (SGA) infant; placental abruption; deep vein thrombosis; stillbirth; recurrent miscarriage; and preterm birth. ;Neonatal parameters: birth weight; head circumference; head length; placental weight; developmental status; DNA damage; congenital heart disease; neural tube defects; and other congenital malformations. ; | — |
Countries
China
Contacts
Public ContactLimin Peng
The First Affiliated Hospital of Heilongjiang University of Chinese Medicine
Outcome results
None listed