NCT00111267

Brief Summary

The purpose of this trial is to study the effects of oral vitamin B12 supplementation and vitamin B12 combined with folic acid supplementation on cognitive performance for 24 weeks in elderly people with mild vitamin B12 deficiency.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2005

Completed
Last Updated

June 24, 2005

Status Verified

May 1, 2005

First QC Date

May 18, 2005

Last Update Submit

June 23, 2005

Conditions

Cognitive DeclineCognitive Symptoms

Keywords

vitamin B12cognitive functionoral supplementationelderly

Outcome Measures

Primary Outcomes (1)

  • Cognitive performance in the domains of attention, concentration, memory, executive function, speed

Secondary Outcomes (1)

  • Blood biochemistry including vitamin B12, methylmalonic acid, holotranscobalamin, homocysteine, and red blood cell folate

Interventions

vitamin B12 supplementationBEHAVIORAL
vitamin B12 + folic acid combined supplementationBEHAVIORAL

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Mild vitamin B12 deficiency:
  • Low plasma vitamin B12 concentration (100 \< B12 \< 300 pmol/L)
  • Elevated methylmalonic acid (MMA) concentration (\> 0.32 umol/L)
  • Creatinine concentration \< 120 umol/L

You may not qualify if:

  • Severe cognitive impairment
  • Anemia
  • Gastrointestinal surgery or diseases
  • Use of vitamin B12 injections or supplements containing \> 25 ug vitamin B12 and/or 200 ug folic acid
  • \< 90% compliance during a 2 week placebo run in period
  • No written informed consent
  • Participation in other research studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University

Wageningen, Gelderland, 6700 EV, Netherlands

Location

MeSH Terms

Conditions

Cognitive DysfunctionNeurobehavioral Manifestations

Interventions

Vitamin B 12

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 18, 2005

First Posted

May 19, 2005

Study Start

May 1, 2003

Study Completion

January 1, 2005

Last Updated

June 24, 2005

Record last verified: 2005-05

Locations

NL(1)