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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
380
One folic acid tablet and one low-dose Vitamin D3 tablet administered orally once daily at breakfast for 6 months.
One folic acid tablet and one high-dose Vitamin D3 tablet administered orally once daily at breakfast for 6 months.
Two starch placebo tablets administered orally once daily at breakfast for 6 months. The placebo is identical in appearance, color, and smell to the active tablets.
Capital Medical University
Beijing, Beijing Municipality, China
Change in Global Cognitive Function Assessed by Montreal Cognitive Assessment (MoCA) Score
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.
Time frame: Baseline and 6 months
Change in Serum 25-hydroxyvitamin D [25(OH)D] Levels
Serum concentrations of 25(OH)D will be measured to assess the response to Vitamin D3 supplementation.
Time frame: Baseline and 6 months
Change in Serum Folic Acid Levels
Serum concentrations of folic acid will be measured to assess the response to folic acid supplementation.
Time frame: Baseline and 6 months
Change in 27-hydroxycholesterol (27-OHC) Levels
Levels of 27-OHC and its metabolites in biological samples (blood/urine/feces) will be measured to explore the underlying metabolic mechanisms.
Time frame: Baseline and 6 months
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