Effect of Vitamin D and Folic Acid on Mild Cognitive Impairment

NCT07486141 | Active Not Recruiting

• 1 other identifier: Z2025SY068
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

Vitamin D; Folic Acid

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 months

Secondary Outcomes (3)

• 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

Study Arms (3)

800IU/d Vitamin D3 + Folic Acid

EXPERIMENTAL

Participants will receive one folic acid(0.4mg/d) tablet and one low-dose(800IU/d) Vitamin D3 tablet orally once daily at breakfast for 6 months.

Dietary Supplement: Vitamin D3 (800 IU/d) and Folic Acid(0.4mg/d)

1600IU/d Vitamin D3 + Folic Acid

EXPERIMENTAL

Participants will receive one folic acid(0.4mg/d) tablet and one high-dose(1600IU/d) Vitamin D3 tablet orally once daily at breakfast for 6 months.

Dietary Supplement: Vitamin D3 (1600 IU/d) and Folic Acid(0.4mg/d)

Placebo

PLACEBO COMPARATOR

Participants will receive two starch placebo tablets (identical in appearance, color, and smell to the active supplements) orally once daily at breakfast for 6 months.

Other: Starch Placebo

Interventions

Vitamin D3 (800 IU/d) and Folic Acid(0.4mg/d) DIETARY_SUPPLEMENT

One folic acid tablet and one low-dose Vitamin D3 tablet administered orally once daily at breakfast for 6 months.

800IU/d Vitamin D3 + Folic Acid

Vitamin D3 (1600 IU/d) and Folic Acid(0.4mg/d) DIETARY_SUPPLEMENT

One folic acid tablet and one high-dose Vitamin D3 tablet administered orally once daily at breakfast for 6 months.

1600IU/d Vitamin D3 + Folic Acid

Starch Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Capital Medical University

Beijing, Beijing Municipality, 100069, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cholecalciferol; Folic Acid

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Rong Xiao, PhD

  Capital Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral student

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 20, 2026
• Study Start: November 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: June 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

CN (1)