Contact information
Type
Scientific
Primary contact
Dr Bernard Favrat
ORCID ID
Contact details
Bugnon 44
Lausanne
1011
Switzerland
+41 (0)21 314 4906
bernard.favrat@hospvd.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
To evaluate the clinical and biological impact of oral vitamin B12 therapy among patients with a serum vitamin B12 level below 200 pmole/l
Ethics approval
The study was approved by the Ethical Review Committee for Clinical Research, Department of Internal Medicine, University of Lausanne, Switzerland
Study design
Placebo-controlled, double-blind, randomized trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Cobalamin deficiency
Intervention
Oral vitamin B12 versus placebo
Intervention type
Supplement
Phase
Not Specified
Drug names
Oral vitamin B12
Primary outcome measures
Evolution of biological markers (serum vitamin B12 level, serum methymalonic acid and homocystein levels)
Secondary outcome measures
Clinical evolution (hematologic, neurologic, psychiatric)
Overall trial start date
01/01/2004
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Patients suspected of cobalamin deficiency with serum vitamin B12 level between 125 and 200 pmole/l. Patients with serum vitamin B12 level below 125 pmole/l were followed-up openly with oral cobalamin.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 (20 in each group)
Participant exclusion criteria
Unwillingness to participate
Recruitment start date
01/01/2004
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Switzerland
Trial participating centre
Bugnon 44
Lausanne
1011
Switzerland
Sponsor information
Organisation
Medical Outpatient Clinic, University of Lausanne (Switzerland)
Sponsor details
Bugnon 44
Lausanne
1011
Switzerland
+41 (0)21 314 4906
bernard.favrat@hospvd.ch
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Medical Outpatient Clinic, University of Lausanne
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
1. 2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21232119
Publication citations
-
Results
Favrat B, Vaucher P, Herzig L, Burnand B, Ali G, Boulat O, Bischoff T, Verdon F, Oral vitamin B12 for patients suspected of subtle cobalamin deficiency: a multicentre pragmatic randomised controlled trial., BMC Fam Pract, 2011, 12, 2, doi: 10.1186/1471-2296-12-2.