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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Bernard Favrat
Scientific

Bugnon 44
Lausanne
1011
Switzerland

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

Study design	Placebo-controlled, double-blind, randomized trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(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) studied	Cobalamin deficiency
Intervention	Oral vitamin B12 versus placebo
Intervention type	Supplement
Primary outcome measure	Evolution of biological markers (serum vitamin B12 level, serum methymalonic acid and homocystein levels)
Secondary outcome measures	Clinical evolution (hematologic, neurologic, psychiatric)
Overall study start date	01/01/2004
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	40 (20 in each group)
Key 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.
Key exclusion criteria	Unwillingness to participate
Date of first enrolment	01/01/2004
Date of final enrolment	31/12/2005

Bugnon 44

Lausanne
1011
Switzerland

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

Bugnon 44
Lausanne
1011
Switzerland

University/education

Medical Outpatient Clinic, University of Lausanne

No information available

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

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