Effects and Mechanisms of Vitamin D Combined With Folic Acid and Vitamin B12 on Mild Cognitive Impairment Via Regulation of Key Factors in 27-Hydroxycholesterol Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Change in Global Cognitive Function Assessed by Montreal Cognitive Assessment (MoCA) Score
研究概览
简要总结
The purpose of this study is to investigate the effects of Vitamin D3 combined with Folic Acid on mild cognitive impairment (MCI). Participants aged 50 to 70 years with MCI will be randomly assigned to three groups: a low-dose Vitamin D3 plus Folic Acid group, a high-dose Vitamin D3 plus Folic Acid group, and a placebo group. The intervention will last for 6 months. The main goal is to observe whether this nutritional intervention can improve or delay the decline of cognitive function.
详细描述
Mild cognitive impairment (MCI) is a critical transitional stage between normal aging and Alzheimer's disease (AD). Designing precise dietary and nutritional interventions is a vital strategy for preventing and treating MCI. Based on an established cohort study, this randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy of combining Vitamin D3 and Folic Acid in MCI patients.
The study will analyze changes in overall and multi-dimensional cognitive functions before and after the 6-month intervention. Furthermore, the study will explore the underlying mechanisms by analyzing biological samples (blood, urine, and feces) for alterations in 27-hydroxycholesterol (27-OHC) and its metabolites, active Vitamin D3, Folic Acid levels, CYP27A1 activity, and related gene polymorphisms. The findings will help determine the optimal interaction ratio and effective dosage of this combined nutritional intervention for delaying cognitive decline.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 50 to 70 years old.
- •Derived from the established elderly chronic disease and health cohort.
- •Meet the diagnostic criteria for Mild Cognitive Impairment (MCI) (e.g., indicated by specific cut-off scores on the MoCA adjusted for education level).
- •Volunteered to participate, able to cooperate with the cognitive assessments, and signed the informed consent form.
排除标准
- •Diagnosis of Alzheimer's disease, other types of dementia, or severe psychiatric disorders (e.g., severe depression, schizophrenia).
- •History of severe neurological diseases (e.g., stroke, brain tumor, brain trauma) that may affect cognitive function.
- •Severe visual or hearing impairments that prevent the completion of cognitive tests.
- •Patients with liver diseases (e.g., hepatitis, liver cirrhosis) or kidney diseases (e.g., nephritis, kidney stones, renal failure).
- •Patients with hypercalcemia (serum calcium concentration > 10.5 mg/dl).
- •Patients with severe anemia, severe malnutrition, or abnormal thyroid function.
- •Current use or use within the past 3 months of cognition-improving drugs, Vitamin D, or Folic Acid supplements, and unwilling to undergo a 3-month washout period prior to the intervention.
结局指标
主要结局
Change in Global Cognitive Function Assessed by Montreal Cognitive Assessment (MoCA) Score
时间窗: Baseline and 6 months
Global cognitive function is evaluated using the Montreal Cognitive Assessment (MoCA). The MoCA assesses different cognitive domains including attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total score ranges from 0 to 30. Higher scores indicate better cognitive performance.
次要结局
- Change in Serum 25-hydroxyvitamin D [25(OH)D] Levels(Baseline and 6 months)
- Change in Serum Folic Acid Levels(Baseline and 6 months)
- Change in 27-hydroxycholesterol (27-OHC) Levels(Baseline and 6 months)
研究者
Jiaxuan Tao
Doctoral student
Capital Medical University