B-vitamins Treatment for Improvement of Cognitive Function

Cognitive Function Clinical Trial

Official title:

Effect of B-Vitamins on Cognitive Function in Elderly People

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095211
• Other study ID #: Elderly St.Ingbert
• Status: Completed
• Phase: N/A
• Start date: January 2003
• Est. completion date: December 2009

Study information

• Verified date: May 2018
• Source: Saarland University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Observation studies documented a correlation between plasma concentrations of homocysteine and cognitive decline with age. The study hypothesis was that high doses of B-vitamins (as effective homocysteine lowering treatment) can improve cognitive function in elderly people.

Description:

We performed a treatment with therapeutic doses of B-vitamins (folic acid, cobalamin, vitamin B6) for 45 days. We collected blood and tested the concentrations of the metabolic markers in blood at start, 3 weeks later and at the end. Cognitive function was tested at start and at the end.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: December 2009
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• age > 65 years and glomerular filtration rate (GFR) > 35 ml/min

Exclusion Criteria:

• acute cancer or those who had coronary or cerebral event or thrombosis in the last 3 months were not eligible for the study.

• furthermore, people who had dementia (mini-mental state-examination scores MMSE < 15)

• those treated with B-vitamins

• those with renal insufficiency

• those receiving drugs that affect Hcy-metabolism (methotrexate, anti-epileptics, L-dopa) were not allowed to participate

Related Conditions & MeSH terms

• Cognitive Function
• Metabolic Improvements

Intervention

Drug:
• B-vitamin complex
5 mg Folic acid, plus 1 mg cyanocobalamin and 40 mg vitamin B6) oral/ day. The placebo capsule contained 400 mg of mannitol: aerosil (99.5: 0.5). In addition, 1 mg/s.c cyanocobalamin daily

Locations

Country	Name	City	State
Germany	Dr. Eckert-	Sankt Ingbert	Saarland

Sponsors (2)

Lead Sponsor	Collaborator
Saarland University	Geriatrische Rehaklinik

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive function		baseline and 45 days later