Mild Cognitive ImpairmentNCT07486141
Effect of Vitamin D and Folic Acid on Mild Cognitive Impairment
A study testing Vitamin D3 (800 IU/d) and Folic Acid(0.4mg/d) and Vitamin D3 (1600 IU/d) and Folic Acid(0.4mg/d) in people with Mild Cognitive Impairment, run by Capital Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Vitamin D3 (800 IU/d) and Folic Acid(0.4mg/d) and Vitamin D3 (1600 IU/d) and Folic Acid(0.4mg/d)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Vitamin D3 (800 IU/d) and Folic Acid(0.4mg/d), Vitamin D3 (1600 IU/d) and Folic Acid(0.4mg/d), Starch Placebo
- Keywords
- Vitamin D, Folic Acid
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Starch PlaceboOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Starch Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months
Secondary outcomes (3)
Change in Serum 25-hydroxyvitamin D [25(OH)D] Levels
Serum concentrations of 25(OH)D will be measured to assess the response to Vitamin D3 supplementation.
Measured: Baseline and 6 months
Change in Serum Folic Acid Levels
Serum concentrations of folic acid will be measured to assess the response to folic acid supplementation.
Measured: Baseline and 6 months
Change in 27-hydroxycholesterol (27-OHC) Levels
Levels of 27-OHC and its metabolites in biological samples (blood/urine/feces) will be measured to explore the underlying metabolic mechanisms.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 Nov 2024
- Primary completion1 Apr 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiaxuan Tao, Capital Medical University
- Investigators
- Rong Xiao, PhD, Principal investigator, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486141
- Sponsor's protocol ID
- Z2025SY068
- Status last verified
- Oct 2026
- First submitted
- 17 Mar 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07486141
- Acronym / sponsor ID
- Z2025SY068
- Conditions
- Mild Cognitive Impairment
- Keywords
- Vitamin D, Folic Acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 800IU/d Vitamin D3 + Folic Acid | Experimental | Dietary Supplement: Vitamin D3 (800 IU/d) and Folic Acid(0.4mg/d)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. |
| 1600IU/d Vitamin D3 + Folic Acid | Experimental | Dietary Supplement: Vitamin D3 (1600 IU/d) and Folic Acid(0.4mg/d)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. |
| Placebo | Placebo comparator | Other: Starch PlaceboParticipants will receive two starch placebo tablets (identical in appearance, color, and smell to the active supplements) orally once daily at breakfast for 6 months. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | 800IU/d Vitamin D3 + Folic Acid |
| 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. | Dietary supplement | 1600IU/d Vitamin D3 + Folic Acid |
| Starch PlaceboTwo 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. | Other | Placebo |
Primary outcome
Change in Global Cognitive Function Assessed by Montreal Cognitive Assessment (MoCA) Score
Time frame: 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.
3 secondary outcomes
Change in Serum 25-hydroxyvitamin D [25(OH)D] Levels
Time frame: Baseline and 6 months
Change in Serum Folic Acid Levels
Time frame: Baseline and 6 months
Change in 27-hydroxycholesterol (27-OHC) Levels
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rong Xiao, PhD principal investigator
Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 (800 IU/d) and Folic Acid(0.4mg/d) and Vitamin D3 (1600 IU/d) and Folic Acid(0.4mg/d) in people with Mild Cognitive Impairment, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Global Cognitive Function Assessed by Montreal Cognitive Assessment (MoCA) Score (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.