Oral/Intramuscular B12 to Treat Cobalamin Deficiency

Not Applicable

Completed

• Conditions: Vitamin B 12 Deficiency
• Interventions: Drug: oral Cobalamin (vitamin B12); Drug: intramuscular Cobalamin (vitamin B12)

• Registration Number: NCT01476007
• Lead Sponsor: Gerencia de Atención Primaria, Madrid

Brief 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.

Study Timeline

• Study First Submitted: 2011-11-15
• Study First Submitted QC: 2011-11-21
• Study First Posted: 2011-11-22
• Study Start: 2014-07
• Status Verified: 2017-11
• Primary Completion: 2017-11-28
• Study Completion: 2017-11-28
• Last Update Submitted: 2017-11-28
• Last Update Posted: 2017-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 284

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 ...

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral Cobalamin (vitamin B12)	oral Cobalamin (vitamin B12)	oral Cobalamin (vitamin B12)
intramuscular Cobalamin (vitamin B12)	intramuscular Cobalamin (vitamin B12)	intramuscular Cobalamin (vitamin B12)

Primary Outcome Measures

Name	Time	Method
Change from Cobalamin level standardization	1 year	Change from Baseline in Cobalamin level at 52 weeks

Trial Locations

Locations (1)

Gerencia Atención Primaria, Madrid; 🇪🇸 Madrid, Spain