Oral/Intramuscular B12 to Treat Cobalamin Deficiency

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.

Conditions

• Vitamin B 12 Deficiency

Interventions

DRUG

oral Cobalamin (vitamin B12)

Intervention group: oral Optovite® B12 1000 gammas.

DRUG

intramuscular Cobalamin (vitamin B12)

Control group: intramuscular Optovite® B12 1000 gammas.

Sponsors & Collaborators

• Instituto de Salud Carlos III

  collaborator OTHER_GOV

• Gerencia de Atención Primaria, Madrid

  lead OTHER_GOV

Principal Investigators

• Rosario Riesgo, MD · Gerencia Atención Primaria. Madrid

• Teresa Sanz-Cuesta, MD · Gerencia Atención Primaria. Madrid

• Isabel DelCura-González, MD Phd · Gerencia Atención Primaria. Madrid

• Jesús Martín-Fernández, MD Phd · Gerencia Atención Primaria. Madrid

• Sofía Garrido-Elustondo, MD · Gerencia Atención Primaria. Madrid

• Esperanza Escortell-Mayor, MD Phd · Gerencia Atención Primaria. Madrid

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-07-31

Primary Completion

2017-11-28

Completion

2017-11-28

Countries

• Spain

Study Locations