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An open lable randomized controlled trial for folic acid and vitamin B12 versus vitamin C in the intervention of the patients with mild cognitive impairment

An open lable randomized controlled trial for folic acid and vitamin B12 versus vitamin C in the intervention of the patients with mild cognitive impairment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-ROC-16008305
Enrollment
Unknown
Registered
2016-04-19
Start date
2016-05-30
Completion date
Unknown
Last updated
2018-02-19

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

MCI combined intervention group :Folic acid, 0.8mg /day, Vitamin B12 25µg /day, oral, eighteen months
MCI folic acid intervention group :folic acid, 0.8mg /day, oral, eighteen months
MCI vitamin B12 intervention group :vitamin B12 25µg/day, oral, eighteen months
vitamin C control group:Vitamin C 100mg/day

Sponsors

Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Community-based elderly subjects aged more than 65 years old; 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 bronchitissevere hypertensionangina 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. Surgery or diseases of the stomach or small intestine; 6. Visual perception,auditory perceptual disorders or languages communication difficulties,all of which may influence measurement of cognitive function; 7. Alcohol dependence and other psychoactive substance abuse such as antipsychotic drug,benzodiazepines or taking medicine influencing cognitive function; 8. Who have implanted metallic devices such as pacemakers.

Design outcomes

Primary

MeasureTime frame
serum folate;serum vitaminB12;Wdchsler Intelligence Scale(Chinese version);

Secondary

MeasureTime frame
tumor necrosis factor;Interleukin 6 (IL-6);plasma Aß40;S-adenosylmethionine;plasma homocysteine;S-adenosylhomocysteine;

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 20, 2026