Effect of intranasal therapy for vitamin B12 deficiency

Phase 1

• Conditions: Cobalamin (vitamin B12) deficiency; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2013-000356-18-NL
• Lead Sponsor: Stichting Apotheek der Haarlemse Ziekenhuizen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-09
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- 65 years of age or over
- Total cobalamin serum level less than 250 pmol/l
- Suspect for cobalamin deficiency; hyperhomocysteinemia (> 15 micromoles/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 information
- Informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

- Concomitant use intranasally administered medication
- Chronic rhinitis
- Use of cobalamin containing dietary supplements
- Severe Renal impairment i.e. MDRD less than 20 ml/min

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In this study we investigate the effects of two intranasal cobalamin dosing regimens i.e. 1000 microgram administered once every three days and 1000 microgram administered once every day for two weeks, followed by once every week in elderly cobalamin deficient subjects on total transcobalamin and holotranscobalamin concentration.<br><br>The objective of this study is to establish the optimal intranasal cobalamin dosing regimen in elderly.<br>;Secondary Objective: Not applicable;Primary end point(s): Change in total transcobalamin and holotranscobalamin (holoTC) serum concentrations over time.;Timepoint(s) of evaluation of this end point: Total transcobalamin and holotranscobalamin serum concentrations will be established at t = 11, 7, 14, 30, 60 and 90 days.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Changes in methylmalonic acid (MMA) and homocysteïne (tHcy) serum concentrations and changes in Geriatric Depression Scale (GDS) 5 and Mini Mental State Examination (MMSE) scores over time.;Timepoint(s) of evaluation of this end point: Methylmalonicacid and homocysteine serumconctrations will be evaluted at t = 1, 14 and 90 days<br>GDS and MMSE scores will be evaluated at t = 1 and 90 days