Plain English Summary
Background and study aims
Vitamin B12 (also known as cobalamin) is one of the eight B vitamins. It helps keep the body's nerve and blood cells healthy and helps make DNA. A low blood level of vitamin B12 (vitamin B12 deficiency) can cause neurological symptoms such as tingling, numbness, muscle weakness, difficulty walking properly, irritability, confusion and forgetfulness. Vitamin B12 deficiency is treated with intramuscular cobalamin (injected into a muscle). Some have suggested that cobalamin taken orally may be as effective, with the advantages of being easier to take and a lower cost. The effectiveness of oral vitamin B12 on severe neurological symptoms has not been confirmed to date and most doctors still recommend intramuscular cobalamin. The aim of this study is to assess the effectiveness of oral hydroxocobalamin (another form of vitamin B12) for the treatment of vitamin B12 deficiency with neurological symptoms.
Who can participate?
Patients aged 18 to 80 with chronic (long-term) vitamin B12 deficiency with neurological symptoms
What does the study involve?
Participants receive oral hydroxocobalamin daily for 10 days then after that once a month for 2 years. Blood vitamin B12 levels and neurological symptoms are measured before taking hydroxocobalamin and at day 10 and day 90.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Hassan II Hospital (Morroco)
When is the study starting and how long is it expected to run for?
January 2011 to December 2013
Who is funding the study?
Hassan II Hospital (Morroco)
Who is the main contact?
Prof. Zouhayr Souirti
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effectiveness of ORAl hydroxocobalamin in treatment of vitamin B12 deficiency with neurological manifestations: a single-centre, prospective, open-label study
Acronym
ORAB
Study hypothesis
Some investigators have suggested that oral cobalamin treatment may be as effective in the treatment of this condition, with the advantages of ease of administration and lower cost. All these investigators have used oral cyanocobalamin. In this prospective study we have administered oral hydroxocobalamin.
Ethics approval
Ethics Committee of Medicine and Pharmacy, Faculty of Fez, Hassan II Hospital, 21/07/2011
Study design
Single-centre prospective open-label study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Vitamin B12 deficiency
Intervention
1. Oral hydroxocobalamin dose: 15000 ug/day (5000 X 3/day) is administered at days 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
2. After that 15000 ug/month (administered once every month)
3. Total duration of intervention: 2 years
4. Serum vitamin B12: day 0 (before taking hydroxocobalamin), day 10 (10th day of taking hydroxocobalamin), and day 90 (third month)
5. Follow up after 3 months
Intervention type
Drug
Phase
Not Applicable
Drug names
Hydroxocobalamin
Primary outcome measure
Serum vitamin B12 level on days 10 and 90
Secondary outcome measures
1. Haematological parameters : Hemoglobin level, mean corpuscular volume (MCV), reticulocytE number, white cells and platelets
2. Neurological improvement : questionnaires e.g. minimental state examination (MMSE), neurological exam with sense vibration tested by diapazon 128 Hz.
Measured at days 10 and 90
Overall trial start date
03/01/2011
Overall trial end date
30/12/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Presence of neurological signs due to vitamin B12 deficiency, unexplained by other causes, with a rate of serum vitamin B12 <200 pg / ml
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Patients previously treated for vitamin B12 deficiency
2. Patients aged under 18 or over 80 years
3. Patients with vitamin B12 deficiency corrected without resorting to the long-term supplementation
Recruitment start date
03/01/2011
Recruitment end date
30/12/2013
Locations
Countries of recruitment
Morocco
Trial participating centre
Lot 70
Fez
30000
Morocco
Funders
Funder type
Hospital/treatment centre
Funder name
Hassan II Hospital (Morroco)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list