Vitamin D3 (800 IU/d) and Folic Acid(0.4mg/d)Vitamin D3 (1600 IU/d) and Folic Acid(0.4mg/d)Starch Placebo
Vitamin 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.
Vitamin 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.
Starch 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.
Study 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.
Eligibility
Sex
ALL
Min age
50 Years
Max age
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.
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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