Overview

Oral/Intramuscular B12 to Treat Cobalamin Deficiency

Status:
Completed
Trial end date:
2017-11-28
Target enrollment:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gerencia de Atención Primaria, Madrid
Collaborator:
Instituto de Salud Carlos III
Treatments:
Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Vitamins
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 ...