Mild Cognitive Impairment
Conditions
Keywords
Vitamin D, Folic Acid
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTVitamin D3 (800 IU/d) and Folic Acid(0.4mg/d)
One folic acid tablet and one low-dose Vitamin D3 tablet administered orally once daily at breakfast for 6 months.
DIETARY_SUPPLEMENTVitamin D3 (1600 IU/d) and Folic Acid(0.4mg/d)
One folic acid tablet and one high-dose Vitamin D3 tablet administered orally once daily at breakfast for 6 months.
OTHERStarch Placebo
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.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Global Cognitive Function Assessed by Montreal Cognitive Assessment (MoCA) Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum 25-hydroxyvitamin D [25(OH)D] Levels | Baseline and 6 months | Serum concentrations of 25(OH)D will be measured to assess the response to Vitamin D3 supplementation. |
| Change in Serum Folic Acid Levels | Baseline and 6 months | Serum concentrations of folic acid will be measured to assess the response to folic acid supplementation. |
| Change in 27-hydroxycholesterol (27-OHC) Levels | Baseline and 6 months | Levels of 27-OHC and its metabolites in biological samples (blood/urine/feces) will be measured to explore the underlying metabolic mechanisms. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORRong Xiao, PhD
Capital Medical University
Outcome results
None listed