NCT01476007

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: Gerencia de Atención Primaria, Madrid · Other Government
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Vitamin B 12 Deficiency

Interventions

Type	Name	Description
DRUG	oral Cobalamin (vitamin B12)	Intervention group: oral Optovite® B12 1000 gammas.
DRUG	intramuscular Cobalamin (vitamin B12)	Control group: intramuscular Optovite® B12 1000 gammas.

Timeline

• Start date: 2014-07-01
• Primary completion: 2017-11-28
• Completion: 2017-11-28
• First posted: 2011-11-22
• Last updated: 2017-11-29

Locations

1 site across 1 country: Spain