Effectiveness of ORAl hydroxocobalamin in treatment of vitamin B12 deficiency with neurological manifestations

ISRCTN	ISRCTN92106665
DOI	https://doi.org/10.1186/ISRCTN92106665
Protocol serial number	N/A
Sponsor	Hassan II Hospital (Morroco)
Funder	Hassan II Hospital (Morroco)

Submission date: 16/07/2011
Registration date: 02/09/2011
Last edited: 21/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Zouhayr Souirti
Scientific

Lot 70
Wafae 4
Narjis
Fez
30000
Morocco

Study information

Primary study design	Interventional
Study design	Single-centre prospective open-label study
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	Effectiveness of ORAl hydroxocobalamin in treatment of vitamin B12 deficiency with neurological manifestations: a single-centre, prospective, open-label study
Study acronym	ORAB
Study objectives	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(s)	Ethics Committee of Medicine and Pharmacy, Faculty of Fez, Hassan II Hospital, 21/07/2011
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Hydroxocobalamin
Primary outcome measure(s)	Serum vitamin B12 level on days 10 and 90
Key secondary outcome measure(s)	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
Completion date	30/12/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	40
Key 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
Key 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
Date of first enrolment	03/01/2011
Date of final enrolment	30/12/2013

Locations

Countries of recruitment

Morocco

Study participating centre

Lot 70

Fez
30000
Morocco

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2016	21/01/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

21/01/2019: Publication reference added
03/08/2016: Plain English summary added.