Oral/Intramuscular B12 to Treat Cobalamin Deficiency

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-11-28

Brief Summary

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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

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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

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Vitamin B 12 Deficiency

Keywords

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primary health care Vitamin B 12 Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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oral Cobalamin (vitamin B12)

Group Type EXPERIMENTAL

oral Cobalamin (vitamin B12)

Intervention Type DRUG

Intervention group: oral Optovite® B12 1000 gammas.

intramuscular Cobalamin (vitamin B12)

Group Type EXPERIMENTAL

intramuscular Cobalamin (vitamin B12)

Intervention Type DRUG

Control group: intramuscular Optovite® B12 1000 gammas.

Interventions

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oral Cobalamin (vitamin B12)

Intervention group: oral Optovite® B12 1000 gammas.

Intervention Type DRUG

intramuscular Cobalamin (vitamin B12)

Control group: intramuscular Optovite® B12 1000 gammas.

Intervention Type DRUG

Other Intervention Names

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Optovite® Optovite® (intramuscular)

Eligibility Criteria

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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 ...

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Esperanza Escortell

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR