Vitamin B12 (cianocobalamin) defficiency MedDRA version: 14.0 Level: PT Classification code 10047609 Term: Vitamin B12 deficiency System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: OPTOVITE® B12 1.000 gammas
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CIANOCOBALAMINA
CAS Number: 68-19-9
Other descriptive name: CYANOCOBALAMIN
Concentration unit: µ
Sponsors
Consorcio de Apoyo a la Investigación Biomédica en red (CAIBER)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age 65 years or older. -Patients who visit for any reason in primary care and accept participating (signed informed consent). -Vitamin B12 =65 years) yes F.1.3.1 Number of subjects for this age range 320
Exclusion criteria
Exclusion criteria: 1.Having received treatment for B12 deficiency in the last 5 years. 2.Severe neurological symptomatology. 3.Folic acid < 2.3ng/ml. 4.Renal insufficiency in stage 4 (FGE from 15 to 29ml/min) 5.Malabsorption: -Surgery or process with gastrointestinal affectation (affecting terminal ileon) -intestinal inflammatory process: Crohn, ulcerous colitis -celiac disease -chronic pancreatitis. 6.Myelodysplastic syndrome and/or other malignant hematological processes. 7.Hemophiliacs and other coagulation pathologies that contraindicate IM administration, 8.Severe systemic disease. 9.Prior administration (28 days ) of any research treatment. 10.Patients diagnosed with HIV, HBV or HBC in treatment. 11.Hypersensitivity to this substance, to cobalt or to any of its ingredients. 12.Anticoagulated patients. 13.Patients who moved or who could not meet the requirements of the study. 14.Patients with limitations for oral administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the effectiveness of orally administered vitamin B12 compared with intramuscular to reestablish the seric level of vitamin B12 at 8, 26 and 52 weeks in patients = 65 years with B12 deficiency, attended in the primary care centers in the Community of Madrid. ;Secondary Objective: 1.Evaluate the safety of both treatment groups. 2.Analyze the quality of life measured by Euroqol-5D. 3.Describe the satisfaction and preferences with specific questions designed for this project, in both treatment groups. 4.Analyze the degree of compliance measured by counting the unused vials in the oral treatment and the number of injections received in the intramuscular treatment. 5.Describe the sociodemographic profile, living habits and the clinical manifestations of patients with vitamin B12 deficiency ;Primary end point(s): Main outcome variable measured in both groups: Normalization of the levels of plasmatic vitamin B12 (B12>179pg/ml, at 8, 26, 52 weeks)=YES /NO ;Timepoint(s) of evaluation of this end point: At 8, 26, 52 study weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Variables Secondary Result -Level of vitamin B12 (pg/ml) -Adverse events: description, onset and resolution, intensity (degree), evaluation of the relationship of causality with the medication and severity criteria mesured in all visits. -Compliance with treatment: measured by counting the unused vials in the oral treatment and the number of injections received in the intramuscular treatment. -Quality of life, measured by Euroqol-5D questionnaire. -Satisfaction and preferences of patients about form of administration: this will be evaluated at the end of the study with a specific question.;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Countries
Spain
Contacts
Public ContactÁrea de Investigación
Agencia Pedro Laín Entralgo
Outcome results
None listed