Trial | NCT01476007  Report issue

Title

Oral/Intramuscular B12 to Treat Cobalamin Deficiency
Oral Versus Intramuscular Cobalamin to Treat Cobalamin Deficiency: Noninferiority Randomised Controlled Trial Pragmatic and Multi-center in the Primary Healthcare Setting (OB12 Project)

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    cobalamin ...

  • Study Participants

    284
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.
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.
Study Started
Jul 31
2014
Primary Completion
Nov 28
2017
Study Completion
Nov 28
2017
Last Update
Nov 29
2017

Drug oral Cobalamin (vitamin B12)

Intervention group: oral Optovite® B12 1000 gammas.

  • Other names: Optovite®

Drug intramuscular Cobalamin (vitamin B12)

Control group: intramuscular Optovite® B12 1000 gammas.

  • Other names: Optovite® (intramuscular)

oral Cobalamin (vitamin B12) Experimental

oral Cobalamin (vitamin B12)

intramuscular Cobalamin (vitamin B12) Experimental

intramuscular Cobalamin (vitamin B12)

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 ...
No Results Posted