Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/12/2005
Date assigned
20/02/2006
Last edited
27/01/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes