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

• Register: ChiCTR
• Last refreshed on: 25 March 2024
• Main ID: ChiCTR-IOR-16008351
• Date of registration: 2016-04-24
• Prospective Registration: Yes
• Primary sponsor: Tianjin Medical University
• Public title: Effects of folic acid and DHA on elders with mild cognitive impairment: a randomized controlled trial
• Scientific title: Effects of folic acid and DHA on elders with mild cognitive impairment: a randomized controlled trial
• Date of first enrolment: 2016-04-25
• Target sample size: placebo:60;folic acid:60;DHA:60;folic acid+DHA:60;
• Recruitment status: Completed
• URL: https://www.chictr.org.cn/showproj.html?proj=12439
• Study type: Interventional study
• Study design: Parallel
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Guowei Huang
• Affiliation: Tianjin Medical University

• Name: Huan Liu
• Affiliation: Tianjin Medical University

Key inclusion & exclusion 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: 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.

Age minimum: 60
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

ICD:F06.7

Mild Cognitive Impairment (MCI)

Intervention(s)

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;

Primary Outcome(s)

Cognitive function (total intelligence quotient) ;

Secondary Outcome(s)

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

Source(s) of Monetary Support

Nutritional sicience research foundation from BY-HEALTH (TY0151102)

Ethics review

Status: Approved
Approval date: 05/04/2016
Contact:

Hong Qi