Effect of Vitamin D and Folic Acid on Mild Cognitive Impairment

NCT07486141 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2026-03-20

No results posted yet for this 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.

Conditions

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

OTHER

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.

Sponsors & Collaborators

  • Capital Medical University

    lead OTHER

Principal Investigators

  • Rong Xiao, PhD · Capital Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-04-30
Completion
2026-06-30

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07486141 on ClinicalTrials.gov