Oral Versus Intramuscular Cobalamin to treat Cobalamin Deficiency: Noninferiority randomised controlled trial, pragmatic and multi-center in the primary healthcare setting (OB12 project).

Phase 1

Conditions: Vitamin B12 (cianocobalamin) defficiency
MedDRA version: 14.0Level: PTClassification code 10047609Term: Vitamin B12 deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2010-024129-20-ES

Lead Sponsor: Consorcio de Apoyo a la Investigación Biomédica en red (CAIBER)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 320

Inclusion Criteria

-Age 65 years or older.
-Patients who visit for any reason in primary care and accept participating (signed informed consent).
-Vitamin B12 < 179 pg/ml.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 320

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.