Oral/Intramuscular B12 to Treat Cobalamin Deficiency

Vitamin B 12 Deficiency Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01476007
• Other study ID #: 2010-024129-20
• Secondary ID: EC10-(115, 116,
• Status: Completed
• Phase: N/A
• First received: November 15, 2011
• Last updated: November 28, 2017
• Start date: July 2014
• Est. completion date: November 28, 2017

Study information

• Verified date: November 2017
• Source: Gerencia de Atención Primaria, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: November 28, 2017
• Est. primary completion date: November 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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 ...

Related Conditions & MeSH terms

• Vitamin B 12 Deficiency

Intervention

Drug:
• oral Cobalamin (vitamin B12)
Intervention group: oral Optovite® B12 1000 gammas.
• intramuscular Cobalamin (vitamin B12)
Control group: intramuscular Optovite® B12 1000 gammas.

Locations

Country	Name	City	State
Spain	Gerencia Atención Primaria, Madrid	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Gerencia de Atención Primaria, Madrid	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Sanz-Cuesta T, González-Escobar P, Riesgo-Fuertes R, Garrido-Elustondo S, del Cura-González I, Martín-Fernández J, Escortell-Mayor E, Rodríguez-Salvanés F, García-Solano M, González-González R, Martín-de la Sierra-San Agustín MÁ, Olmedo-Lucerón C, Sevillano Palmero ML, Mateo-Ruiz C, Medina-Bustillo B, Valdivia-Pérez A, García-de Blas-González F, Mariño-Suárez JE, Rodríguez-Barrientos R, Ariza-Cardiel G, Cabello-Ballesteros LM, Polentinos-Castro E, Rico-Blázquez M, Rodríguez-Monje MT, Soto-Díaz S, Martín-Iglesias S, Rodríguez-González R, Bretón-Lesmes I, Vicente-Herrero M, Sánchez-Díaz J, Gómez-Gascón T, Drake-Canela M, Asúnsolo-del Barco Á; OB12 Group. Oral versus intramuscular administration of vitamin B12 for the treatment of patients with vitamin B12 deficiency: a pragmatic, randomised, multicentre, non-inferiority clinical trial undertaken in the primary healthcare setting (Project OB12). BMC Public Health. 2012 May 31;12:394. doi: 10.1186/1471-2458-12-394. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Cobalamin level standardization	Change from Baseline in Cobalamin level at 52 weeks	1 year