Cobalamin deficiency in primary care: a placebo-controlled, double-blind, randomized trial

ISRCTN ISRCTN22063938
DOI https://doi.org/10.1186/ISRCTN22063938
Secondary identifying numbers N/A
Submission date
29/12/2005
Registration date
20/02/2006
Last edited
27/01/2011
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

Not provided at time of registration

Contact information

Dr Bernard Favrat
Scientific

Bugnon 44
Lausanne
1011
Switzerland

Phone +41 (0)21 314 4906
Email bernard.favrat@hospvd.ch

Study information

Study designPlacebo-controlled, double-blind, randomized trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesTo 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(s)The study was approved by the Ethical Review Committee for Clinical Research, Department of Internal Medicine, University of Lausanne, Switzerland
Health condition(s) or problem(s) studiedCobalamin deficiency
InterventionOral vitamin B12 versus placebo
Intervention typeSupplement
Primary outcome measureEvolution of biological markers (serum vitamin B12 level, serum methymalonic acid and homocystein levels)
Secondary outcome measuresClinical evolution (hematologic, neurologic, psychiatric)
Overall study start date01/01/2004
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40 (20 in each group)
Key inclusion criteriaPatients 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.
Key exclusion criteriaUnwillingness to participate
Date of first enrolment01/01/2004
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Bugnon 44
Lausanne
1011
Switzerland

Sponsor information

Medical Outpatient Clinic, University of Lausanne (Switzerland)
University/education

Bugnon 44
Lausanne
1011
Switzerland

Phone +41 (0)21 314 4906
Email bernard.favrat@hospvd.ch
ROR logo "ROR" https://ror.org/019whta54

Funders

Funder type

University/education

Medical Outpatient Clinic, University of Lausanne

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 13/01/2011 Yes No