Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/07/2011
Date assigned
02/09/2011
Last edited
03/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Zouhayr Souirti

ORCID ID

Contact details

Lot 70
Wafae 4
Narjis
Fez
30000
Morocco

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 measures

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. mini–mental 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

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

Sponsor information

Organisation

Hassan II Hospital (Morroco)

Sponsor details

Lot 70
Wafae 4
Narjis
Fez
30000
Morocco

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

03/08/2016: Plain English summary added.