Oral/Intramuscular B12 to Treat Cobalamin Deficiency (OB12)

Gerencia de Atención Primaria, Madrid

Status: Completed

Conditions: Vitamin B 12 Deficiency

Treatments: Drug: oral Cobalamin (vitamin B12); Drug: intramuscular Cobalamin (vitamin B12)

Study type: Interventional

Funder types: Other

Identifiers

NCT01476007

2010-024129-20

EC10-(115, 116, 117,119, 122) (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 284 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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 ...

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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284 participants in 2 patient groups

oral Cobalamin (vitamin B12)

Experimental group

Description:

oral Cobalamin (vitamin B12)

Treatment:

Drug: oral Cobalamin (vitamin B12)

intramuscular Cobalamin (vitamin B12)

Experimental group

Description:

intramuscular Cobalamin (vitamin B12)

Treatment:

Drug: intramuscular Cobalamin (vitamin B12)