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Oral/Intramuscular B12 to Treat Cobalamin Deficiency (OB12)

Primary Purpose

Vitamin B 12 Deficiency

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

oral Cobalamin (vitamin B12)

intramuscular Cobalamin (vitamin B12)

About this trial

This is an interventional treatment trial for Vitamin B 12 Deficiency focused on measuring primary health care, Vitamin B 12 Deficiency

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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 ...

Sites / Locations

Gerencia Atención Primaria, Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

oral Cobalamin (vitamin B12)

intramuscular Cobalamin (vitamin B12)

Arm Description

oral Cobalamin (vitamin B12)

intramuscular Cobalamin (vitamin B12)

Outcomes

Primary Outcome Measures

Change from Cobalamin level standardization

Change from Baseline in Cobalamin level at 52 weeks

Secondary Outcome Measures

Full Information

NCT ID

NCT01476007

First Posted

November 15, 2011

Last Updated

November 28, 2017

Sponsor

Gerencia de Atención Primaria, Madrid

Collaborators

Instituto de Salud Carlos III

1. Study Identification

Unique Protocol Identification Number

NCT01476007

Brief Title

Oral/Intramuscular B12 to Treat Cobalamin Deficiency

Acronym

OB12

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

July 2014 (Actual)

Primary Completion Date

November 28, 2017 (Actual)

Study Completion Date

November 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gerencia de Atención Primaria, Madrid

Collaborators

Instituto de Salud Carlos III

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin B 12 Deficiency

Keywords

primary health care, Vitamin B 12 Deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

284 (Actual)

8. Arms, Groups, and Interventions

Arm Title

oral Cobalamin (vitamin B12)

Arm Type

Experimental

Arm Description

oral Cobalamin (vitamin B12)

Arm Title

intramuscular Cobalamin (vitamin B12)

Arm Type

Experimental

Arm Description

intramuscular Cobalamin (vitamin B12)

Intervention Type

Drug

Intervention Name(s)

oral Cobalamin (vitamin B12)

Other Intervention Name(s)

Optovite®

Intervention Description

Intervention group: oral Optovite® B12 1000 gammas.

Intervention Type

Drug

Intervention Name(s)

intramuscular Cobalamin (vitamin B12)

Other Intervention Name(s)

Optovite® (intramuscular)

Intervention Description

Control group: intramuscular Optovite® B12 1000 gammas.

Primary Outcome Measure Information:

Title

Change from Cobalamin level standardization

Description

Change from Baseline in Cobalamin level at 52 weeks

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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 ...

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rosario Riesgo, MD

Organizational Affiliation