Oral/Intramuscular B12 to Treat Cobalamin Deficiency
Status:
Completed
Trial end date:
2017-11-28
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Gerencia de Atención Primaria, Madrid
Collaborator:
Instituto de Salud Carlos III
Treatments:
Hydroxocobalamin Vitamin B 12 Vitamin B Complex Vitamins