An Intervention Trial to Prevent Cognitive Impairment and Depression in Older Men

A randomized, double blind, placebo-controlled trial of homocysteine lowering vitamins to prevent cognitive impairment and depression in older men

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000045617

Enrollment

300

Registered

2005-07-26

Start date

2000-07-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Interventions

Single tablet, once daily, of 2 milligrams of folate, 25 milligrams of B6 and 400 micrograms of B12 for two years of study

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

Male

Age

75 Years to No maximum

Healthy volunteers

Inclusion criteria

Men over the age of 75 years with a previous history of hypertension

Exclusion criteria

Significant cognitive impairment or depression at baseline, the presence of severe illness likely to cause the subject's death within 12 months, residence in a nursing home or long stay hospital,currently taking B group vitamins or food supplements and those subjects who are unable to complete the studys instruments in English.

Outcome results