Please select the eligibility criteria that correspond to the clinical trial below.
Title: Oral Versus Intramuscular Cobalamin to Treat Cobalamin Deficiency: Noninferiority Randomised Controlled Trial Pragmatic and Multi-center in the Primary Healthcare Setting (OB12 Project)
Brief Summary: Objective: To determine the effectiveness of oral versus intramuscular Cobalamin (vitamin B12) by restore cobalamin parameter in blood at 8, 26 and 52 weeks in ≥ 65 aged patients with Cobalamin Deficiency.

Design: Noninferiority randomised controlled trial, pragmatic and multi-center in the primary healthcare setting (Madrid Region).

Participants: ≥ 65 aged patients with Cobalamin Deficiency. Patients give inform consent. Number of patients: 320 (160 each arm). Assignment: randomized simple (automatic system).

Variables. Main outcome variable: Cobalamin level standardization (yes/no). Secondary outcome variables: Adverse events. Adherence measurement of treatment. Health related quality of life questionnaire (Euroqol-5D). Satisfaction and preferences. Other variables: Gender. Age. Live alone. Vegetarian diet. Alcohols consume. Clinic Variables (symptoms and physical examination) and blood parameters. Drugs consume.

Causes of all losses and withdrawals. Number of patients (age and gender) who declined to participate.

All data (excluding patient identification data) will be record in an electronic database.

Intervention group: oral Optovite® B12 1000 gammas. Control group: idem intramuscular.

Analysis: Descriptive analysis (screening phase). Baseline comparison of the two intervention groups. Effect of cobalamin (main outcome variable). Security. Quality of life. Adherence measurement of treatment.


Options:
A: Inclusion Criteria:

* General practitioner's prescription for Vitamin B12 deficiency testing
* Age\> 18 years
* Ability to give written informed consent
* Vitamin B12 serum concentrations \< 200pmol/l
* indication for vitamin B12 supplementation according to the General practitioners estimation

Exclusion Criteria:

* Patients with incorrect intake of vitamin preparations containing vitamin B12
* Patients with previously diagnosed dementia
* Patients with known hereditary transcobalamin transportation defects
* lack of written and/or oral understanding in German, French, Italian or English languages
B: Inclusion Criteria:

* Patients of both sexes (women after menopause, women of child-bearing age after sterilization or if practicing reliable contraception)
* Type 2 DM requiring insulin therapy after failure of maximal oral antidiabetic treatment (glycosylated Hb \> 7.5%) and need for exogenous insulin. (No concomitant use of oral antidiabetic agents)
* Being ambulatory
* Age: 30 to 80 years
* Proven absence of Islet Antibodies, if QI \< 28 kg/m2
* Insulin therapy 4 times daily (21), or insulin therapy 2 times daily using insulin 'mixtures' (rapidly and slowly acting)
* Standard dietary prescription by the dietician
* Absence of keto-acidosis
* Informed consent

Exclusion Criteria:

* Congestive heart failure, NYHA-classes III or IV
* Cardiac failure and/or myocardial infarction in the last four months before enrolment
* Other severe organic / systemic disease
* Metformin-induced lactic-acidosis
* Intolerance to metformin hydrochloride
* Renal disease or renal dysfunction
* Hypoxic states
* Severe hepatic dysfunction
* Excessive alcohol intake, acute or chronic
* Acute or chronic metabolic acidosis
C: Inclusion Criteria:

* Undergone total gastrectomy for gastric cancer
* Regular follow up is possible
* Serum vit,. B12 \< 200pg/ml

Exclusion Criteria:

* Has diseases other than stomach cancer
* Patients with other kinds of oral supplementation (multi-vitamins)
D: Inclusion Criteria:

* ≥ 65 aged patients with Cobalamin Deficiency.
* Patients give inform consent.

Exclusion Criteria:

* Treatment with B12 (1 last year)
* Neurologic or psychiatric pathologies
* Folic acid \< 2.3ng/ml ...

Answer: D