Oral/Intramuscular B12 to Treat Cobalamin Deficiency

Study Overview
=================
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Oral Versus Intramuscular Cobalamin to Treat Cobalamin Deficiency: Noninferiority Randomised Controlled Trial Pragmatic and Multi-center in the Primary Healthcare Setting (OB12 Project)

Conditions
-----------------
Vitamin B 12 Deficiency

Intervention / Treatment
-----------------
* Drug: oral Cobalamin (vitamin B12)
* Drug: intramuscular Cobalamin (vitamin B12)


Participation Criteria
=================
Eligibility Criteria
-----------------
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 ...

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oral Cobalamin (vitamin B12)<br>oral Cobalamin (vitamin B12) | Drug: oral Cobalamin (vitamin B12)<br>* Intervention group: oral Optovite® B12 1000 gammas.<br>* Other names: Optovite®;|
| Experimental: intramuscular Cobalamin (vitamin B12)<br>intramuscular Cobalamin (vitamin B12) | Drug: intramuscular Cobalamin (vitamin B12)<br>* Control group: intramuscular Optovite® B12 1000 gammas.<br>* Other names: Optovite® (intramuscular);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Cobalamin level standardization | Change from Baseline in Cobalamin level at 52 weeks | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary health care, Vitamin B 12 Deficiency