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The effect of vitamin D3 combined with DHA on cognitive function: a randomized, double-blind, placebo-controlled trial

Study on the neuroimmune mechanism of improving cognition by regulating NLRP3 mediated pyroptosis of microglia through the combination of vitamin D3 and DHA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113843
Enrollment
Unknown
Registered
2025-12-03
Start date
2024-02-05
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Mild cognitive impairment

Interventions

VD3 intervention group:Pure VD3 intervention at 800IU/day (400IU/capsule, 2 capsules/day) and DHA placebo capsule at 1 capsule/day.
DHA intervention group:DHA soft capsules 1g/day (1g/capsule, 1 capsule/day) and VD3 placebo 2 capsules/day.
VD3 combined with DHA intervention group:VD3 intervention at 800IU/day (400IU/capsule, 2 capsules/day) and DHA soft capsules at 1g/day (1g/capsule).
Placebo control group:2 VD3 placebo capsules per day and 1 DHA placebo capsule per day.

Sponsors

Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Participants subjectively believe or are objectively confirmed by family members/doctors to have memory impairment; 2. Memory impairment lasts for at least three months; 3. The Mini Mental State Examination (MMSE) score is>= 17 for the illiterate group, >= 20 for the primary school group, and >=24 for the middle school and above group; According to the Activities of Daily Living Scale, if there is no or slight impairment in daily living activities, the ADL score is <= 18 points; 5. Not suitable for dementia AD The criteria for mental illness, brain injury, or any active neuropsychiatric disorder that may lead to cognitive impairment. The diagnostic criteria for dementia are based on the DSM-IV criteria of the American Psychiatric Association and the National Institute of Neurology, Language Disorders, and Stroke Alzheimer's and Related Disorders (NINCDS-ADRDA) criteria, combined with medical history and other data for dementia diagnosis. Using HIS to differentiate between AD and vascular dementia. Suspected MCI and senile dementia patients will be further diagnosed by neurologists.

Exclusion criteria

Exclusion criteria: 1. Clinical diagnosis of AD, PD or other dementia; 2. Having serious organ dysfunction, malignant tumors, or other major diseases that can affect cognitive function; 3. Have taken nutritional supplements that interfere with vitamin D3 or DHA metabolism within the past 3 months prior to recruitment. 4. Medical conditions that prohibit the use of vitamin D3 or DHA.

Design outcomes

Primary

MeasureTime frame
Full intelligence quotient;

Secondary

MeasureTime frame
AD related biomarkers (APP, PS1,PS2);Proinflammatory cytokine(IL-1ß, IL-18, Aß40, Aß42);NLRP3 inflammasome pathway related proteins(NLRP3, GSDMD, caspase-1);Basic Information of the Research Subjects;

Countries

China

Contacts

Public ContactFei Ma

Tianjin Medical University

mafei@tmu.edu.cn+86 138 2156 3872

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026