B-vitamins Treatment for Improvement of Cognitive Function | NCT01095211

Studies
B-vitamins Treatment for Improvement of Cognitive Function

NCT01095211

Sponsor

Universität des Saarlandes

Status

Completed

Last Update Posted

May 11, 2018Actual

Enrollment

79Actual

Phase

Not Applicable

Conditions

Cognitive Function
Metabolic Improvements

Interventions

B-vitamin complex

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Sep 2005Actual

Completion Date

Dec 2009Actual

First Submitted Date

Mar 29, 2010

First Submission Date that Met QC Criteria

Mar 29, 2010

First Posted Date

Mar 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2018

Last Update Posted Date

May 11, 2018Actual

Name	Class
Geriatrische Rehaklinik	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

79Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
B-Vitamins	Active Comparator	folic acid, cobalamin, vitamin B6	Drug: B-vitamin complex
placebo	Placebo Comparator	none of the vitamins (99.5% mannitol)	Drug: B-vitamin complex

Interventions

Name	Type	Description	Arm Group Labels	Other Names
B-vitamin complex	Drug	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

Measure	Description	Time Frame
Cognitive function		baseline and 45 days later

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rima Obeid	Department of Clinical Chemistry, University of Saarland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Eckert-		Sankt Ingbert	Saarland	66386	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D005492	Folic Acid

Ancestor Terms

ID	Term
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

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Browse Branches

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