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
Scientific
Bugnon 44
Lausanne
1011
Switzerland
Phone | +41 (0)21 314 4906 |
---|---|
bernard.favrat@hospvd.ch |
Study information
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 |
Eligibility
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 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Bugnon 44
Lausanne
1011
Switzerland
1011
Switzerland
Sponsor information
Medical Outpatient Clinic, University of Lausanne (Switzerland)
University/education
University/education
Bugnon 44
Lausanne
1011
Switzerland
Phone | +41 (0)21 314 4906 |
---|---|
bernard.favrat@hospvd.ch | |
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 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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 13/01/2011 | Yes | No |