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B-vitamins Treatment for Improvement of Cognitive Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01095211
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
Geriatrische Rehaklinik
Information provided by:
Saarland University

Brief 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.

Condition or disease Intervention/treatment Phase
Cognitive Function Metabolic Improvements Drug: B-vitamin complex Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Effect of B-Vitamins on Cognitive Function in Elderly People
Study Start Date : January 2003
Actual Primary Completion Date : September 2005
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins

Arm Intervention/treatment
Active Comparator: B-Vitamins
folic acid, cobalamin, vitamin B6
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
Other Name: no other names

Placebo Comparator: placebo
none of the vitamins (99.5% mannitol)
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
Other Name: no other names




Primary Outcome Measures :
  1. Cognitive function [ Time Frame: baseline and 45 days later ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095211


Locations
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Germany
Dr. Eckert-
Sankt Ingbert, Saarland, Germany, 66386
Sponsors and Collaborators
Saarland University
Geriatrische Rehaklinik
Investigators
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Principal Investigator: Rima Obeid Department of Clinical Chemistry, University of Saarland

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Responsible Party: Dr. Eckert, Kreiskrankenhaus St. Ingbert GmbH
ClinicalTrials.gov Identifier: NCT01095211     History of Changes
Other Study ID Numbers: Elderly St.Ingbert
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Saarland University:
folic acid
homocysteine
MMSE scores
methyl malonic acid
betaine

Additional relevant MeSH terms:
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Vitamins
Folic Acid
Vitamin B Complex
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics