NCT06641245尚未招募不适用
PREconception Folic Acid Clinical Efficacy (PREFACE) Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 272
- 主要终点
- RBC folate
研究概览
简要总结
A study to help understand what forms of folic acid are most effective to increase folate status during pregnancy for the best protection against neural tube defects
详细描述
A multisite randomized controlled trial to determine whether supplementation with (6S)-5-methyltetrahydrofolic acid (5-MTHF) is at least as effective as synthetic folic acid in increasing maternal folate status for protection against neural tube defects (NTDs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non-pregnant females who are:
- •Currently trying to become pregnant;
- •Aged 19-42 years;
- •Low risk for an NTD-affected pregnancy
排除标准
- •Trying to conceive for ≥6 months (as ~90% of pregnancies occur after 6 months of trying);
- •Diagnosed ovulatory disorders (polycystic ovary syndrome, endometriosis, or menstrual irregularity);
- •More than 2 miscarriages in the past year;
- •Undergoing fertility assistance (including current IVF or intrauterine insemination);
- •Pre-existing medical condition known to impact maternal folate status (malabsorptive and inflammatory bowel diseases, active celiac disease, gastric bypass surgery, type 1 or 2 diabetes mellitus);
- •Lifestyle factors known to impact maternal folate status (current smoking, >6 alcoholic drinks per week, recreational drug use);
- •On the female or male side of those trying to conceive: personal NTD history, previous NTD-affected pregnancy, or personal or family history of other folate sensitive congenital anomalies;
- •Use of folate-inhibiting medications (Chloramphenicol, Methotrexate, Metformin, Sulfasalazine, Phenobarbital, Phenytoin, Primidone, Triamterene, Barbiturates).
结局指标
主要结局
RBC folate
时间窗: At 6 (± 2) wks gestation (approximate time of neural tube closure)
•Maternal RBC folate concentrations (nmol/L)
次要结局
- Maternal plasma placental growth factor (pg/mL)(At 18 (± 1) and 30 (± 1) wks gestation)
研究者
Crystal Karakochuk
Associate Professor, Human Nutrition
University of British Columbia
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