NCT07486141

Effect of Vitamin D and Folic Acid on Mild Cognitive Impairment

Effects and Mechanisms of Vitamin D Combined With Folic Acid and Vitamin B12 on Mild Cognitive Impairment Via Regulation of Key Factors in 27-Hydroxycholesterol Metabolism

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 380 (actual)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild Cognitive Impairment

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-04-01
• Completion: 2026-06-01
• First posted: 2026-03-20
• Last updated: 2026-03-20

Locations

1 site across 1 country: China