Effectiveness of ORAl hydroxocobalamin in treatment of vitamin B12 deficiency with neurological manifestations
| ISRCTN | ISRCTN92106665 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92106665 |
| Secondary identifying numbers | N/A |
- 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
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
Scientific
Lot 70
Wafae 4
Narjis
Fez
30000
Morocco
Study information
| Study design | Single-centre prospective open-label study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 03/01/2011 |
| Completion date | 30/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
30000
Morocco
Sponsor information
Hospital/treatment centre
Lot 70
Wafae 4
Narjis
Fez
30000
Morocco
"ROR" |
https://ror.org/03m2nqg26 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
21/01/2019: Publication reference added
03/08/2016: Plain English summary added.
