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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
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.
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.
Age
50 - 70 years
Sex
ALL
Healthy Volunteers
No
Capital Medical University
Beijing, Beijing Municipality, China
Start Date
November 1, 2024
Primary Completion Date
April 1, 2026
Completion Date
June 1, 2026
Last Updated
March 20, 2026
380
ACTUAL participants
Vitamin D3 (800 IU/d) and Folic Acid(0.4mg/d)
DIETARY_SUPPLEMENT
Vitamin D3 (1600 IU/d) and Folic Acid(0.4mg/d)
DIETARY_SUPPLEMENT
Starch Placebo
OTHER
Lead Sponsor
Capital Medical University
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06780917