Effect of repeated intranasal cobalamin (Vitamin B12) administration on cobalamin deficiency in elderly
Completed
- Conditions
- Vitamin B12 deficiency10047635
- Registration Number
- NL-OMON45137
- Lead Sponsor
- Kennemer Gasthuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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
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 < 19
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change in total transcobalamin and holotranscobalamin (holoTC)<br /><br>serumconcentrations over time.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Change in methylmalonic acid (MMA) and homocysteïne (tHcy) serum concentrations<br /><br>and change in Geriatric Depression Scale (GDS) 5 and Mini Mental State<br /><br>Examination (MMSE) score over time.</p><br>