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Effects of folic acid and DHA on elders with mild cognitive impairment: a randomized controlled trial

Effects of folic acid and DHA on elders with mild cognitive impairment: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16008351
Enrollment
Unknown
Registered
2016-04-24
Start date
2016-04-25
Completion date
Unknown
Last updated
2024-03-25

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:placebo, oral, six months
folic acid:folic acid, 0.8mg/day, oral, six months
DHA:DHA 800mg/day, oral, six months
folic acid+DHA:folic acid (0.8mg/day) + DHA (800mg/day), oral, six months

Sponsors

Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Community-based elderly subjects aged 60 or older; 2. Memory complaints reported by the patient, family, or physician, of at least a 6-month duration and preferably corroborated by an informant; 3. Mild quantitative impairments in cognitive function were assessed by the Chinese version of the 30-point Mini Mental State Examination (MMSE) using age- and education-based norms (cutoff point was set at 1.5 SD below the mean age- and education-adjusted MMSE scores); 4. Decreased daily living ability and social function, as measured by the daily living scale, score is below 18; 5. Absence of dementia (according to DSM-IV criteria), psychiatric disorder, cerebral damage, or any active neuropsychiatric condition producing disability. Subjects conforming to five items above can be determined as MCI and included in our study.

Exclusion criteria

Exclusion criteria: 1. Neurological examination found the sign of local central nerve obstruction such as obvious paralysisunilateral sensory disturbance and aphasia etc, history of cerebrovascular diseases (hemorrhagic and ischemic stroke), brain injury or bone fracture; 2. Medical diseases such as asthmatic bronchitis, severe hypertension, angina pectoris and severe infection; 3. Psychotic patients with evident anxiety and depressed emotion and subjects with endocrine system history of disease(hyperthyroidism, thyroid hypofunction, systemic lupus eythematosus, rheumatoid arthritis); 4. Newly discovered or advanced tumor; 5. Visual perception,auditory perceptual disorders or languages communication difficulties, all of which may influence measurement of cognitive function; 6. Alcohol dependence and other psychoactive substance abuse such as antipsychotic drug,benzodiazepines or taking medicine influencing cognitive function.

Design outcomes

Primary

MeasureTime frame
Cognitive function (total intelligence quotient) ;

Secondary

MeasureTime frame
Folate and methionine circulating metabolites;DHA and NPD1;AD-related genes expression;Inflammatory factors;DNA methyltransferases;

Countries

China

Contacts

Public ContactGuowei Huang

Tianjin Medical University

huangguowei@tmu.edu.cn+86 22 83336606

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 24, 2026