Vitamin B12 deficiency
Conditions
Interventions
patients will be randomised over two intranasal dosage regimens.
Arm A:
1000 microgam every day for two weeks, followed by 1000 microgram once every
week for three months (90 days).
Arm B:
1000 mic
Sponsors
Kennemer Gasthuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 65 years of age or over, Cobalaminconcentration less than 250 pmol/l, Suspect for cobalamin deficiency; hyperhomocysteinemia (> 15 micromol/l) and/or 2 or more symptoms of cobalamin deficiency e.g. fatigue, memory impairment, irritability, personality changes, muscle weakness, depression, poor appetite, weight loss Capable of understanding the study informaton Informed consent
Exclusion criteria
Exclusion criteria: Concomitant use of intranasally administered medication, Chronic rhinitis, Use of cobalamin containing dietary supplements, Severe Renal impairment i.e. MDRD less than 20 ml/min, MMSE score
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total transcobalamin and holotranscobalamin (holoTC) serumconcentrations over time. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in methylmalonic acid (MMA) and homocysteïne (tHcy) serum concentrations and change in Geriatric Depression Scale (GDS) 5 and Mini Mental State Examination (MMSE) score over time. | — |
Countries
Netherlands
Outcome results
None listed