Intervention study for vitamin D combined with folic acid and vitamin B12 on patients with mild cognitive impairment

The role and mechanism of vitamin D combined with folic acid and vitamin B12 regulates key factors in 27-hydroxycholesterol metabolism on improving the occurrence of mild cognitive impairment

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900025452

Enrollment

Unknown

Registered

2019-08-26

Start date

2019-09-01

Completion date

Unknown

Last updated

2019-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment (MCI)

Interventions

placebo group:daily oral dose of one tablet consisting of placebo, six months

VD intervention group:daily oral 600IU vitamin D3, six months

VD-FA/VB12 intervention group:daily oral 800IU vitamin D3, 400µg folic acid and 25µg vitamin B12, six months

FA/VB12 intervention group:daily oral 400µg folic acid and 25µg vitamin B12, six months

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. MCI population from a two-side study cohort of established multi-center dietary cholesterol and MCI/AD risk; 2. Informed consent, voluntary participation can complete the project, and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Suffering from hepatitis, liver cirrhosis and other liver diseases; 2. Nephritis, kidney stones, kidney failure and other kidney diseases; 3. Hypercalcemia (serum calcium concentration >10.5mg / dl), severe vitamin B12 deficiency (100nmol / l; 4. Severe anemia, severe malnutrition and thyroid dysfunction; 5. In the past 3 months to take drugs to improve cognitive or vitamin D, folic acid and vitamin B12 Supplements, and refuse to stop self-administered vitamin supplements; 6. Vacation in sunny areas within 4 weeks or plan to spend vacations in sunny areas during 12-week interventions; 7. Women with fertility, and less than 3 menopause years; 8. Primary school and below; 9. Celiac disease, lipid malabsorption.

Design outcomes

Primary

Measure	Time frame
MoCA grades;27-OHC and its related synthetase;	—

Secondary

Measure	Time frame
Serum vitamin D, Hcy, vitamin B12, oxysterol, etc.;	—

Countries

China

Contacts

Public ContactXiao Rong

School of Public Health, Capital Medical UniversitySchool of Public Health, Capital Medical University

xiaor22@ccmu.edu.cn+86 18611314617

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026