NCT01476007

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
284

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
2.6 years until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2017

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

3.4 years

First QC Date

November 15, 2011

Last Update Submit

November 28, 2017

Conditions

Vitamin B 12 Deficiency

Keywords

primary health careVitamin B 12 Deficiency

Outcome Measures

Primary Outcomes (1)

  • Change from Cobalamin level standardization

    Change from Baseline in Cobalamin level at 52 weeks

    1 year

Study Arms (2)

oral Cobalamin (vitamin B12)

EXPERIMENTAL

oral Cobalamin (vitamin B12)

Drug: oral Cobalamin (vitamin B12)

intramuscular Cobalamin (vitamin B12)

EXPERIMENTAL

intramuscular Cobalamin (vitamin B12)

Drug: intramuscular Cobalamin (vitamin B12)

Interventions

oral Cobalamin (vitamin B12)DRUG

Intervention group: oral Optovite® B12 1000 gammas.

Also known as: Optovite®
oral Cobalamin (vitamin B12)
intramuscular Cobalamin (vitamin B12)DRUG

Control group: intramuscular Optovite® B12 1000 gammas.

Also known as: Optovite® (intramuscular)
intramuscular Cobalamin (vitamin B12)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • ≥ 65 aged patients with Cobalamin Deficiency.
  • Patients give inform consent.

You may not qualify if:

  • Treatment with B12 (1 last year)
  • Neurologic or psychiatric pathologies
  • Folic acid \< 2.3ng/ml ...

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gerencia Atención Primaria, Madrid

Madrid, 28035, Spain

Location

Related Publications (2)

  • Sanz-Cuesta T, Gonzalez-Escobar P, Riesgo-Fuertes R, Garrido-Elustondo S, del Cura-Gonzalez I, Martin-Fernandez J, Escortell-Mayor E, Rodriguez-Salvanes F, Garcia-Solano M, Gonzalez-Gonzalez R, Martin-de la Sierra-San Agustin MA, Olmedo-Luceron C, Sevillano Palmero ML, Mateo-Ruiz C, Medina-Bustillo B, Valdivia-Perez A, Garcia-de Blas-Gonzalez F, Marino-Suarez JE, Rodriguez-Barrientos R, Ariza-Cardiel G, Cabello-Ballesteros LM, Polentinos-Castro E, Rico-Blazquez M, Rodriguez-Monje MT, Soto-Diaz S, Martin-Iglesias S, Rodriguez-Gonzalez R, Breton-Lesmes I, Vicente-Herrero M, Sanchez-Diaz J, Gomez-Gascon T, Drake-Canela M, Asunsolo-del Barco A; 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.

    PMID: 22650964BACKGROUND

  • Sanz-Cuesta T, Escortell-Mayor E, Cura-Gonzalez I, Martin-Fernandez J, Riesgo-Fuertes R, Garrido-Elustondo S, Marino-Suarez JE, Alvarez-Villalba M, Gomez-Gascon T, Gonzalez-Garcia I, Gonzalez-Escobar P, Vargas-Machuca Cabanero C, Noguerol-Alvarez M, Garcia de Blas-Gonzalez F, Banos-Morras R, Diaz-Laso C, Caballero-Ramirez N, Herrero de-Dios A, Fernandez-Garcia R, Herrero-Hernandez J, Pose-Garcia B, Sevillano-Palmero ML, Mateo-Ruiz C, Medina-Bustillo B, Aguilar-Jimenez M; OB12 Group. Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care: a pragmatic, randomised, non-inferiority clinical trial (OB12). BMJ Open. 2020 Aug 20;10(8):e033687. doi: 10.1136/bmjopen-2019-033687.

    PMID: 32819927DERIVED

MeSH Terms

Conditions

Vitamin B 12 Deficiency

Interventions

Vitamin B 12Injections, Intramuscular

Condition Hierarchy (Ancestors)

Vitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic CompoundsInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Rosario Riesgo, MD

    Gerencia Atención Primaria. Madrid

    PRINCIPAL INVESTIGATOR

  • Teresa Sanz-Cuesta, MD

    Gerencia Atención Primaria. Madrid

    STUDY DIRECTOR

  • Isabel DelCura-González, MD Phd

    Gerencia Atención Primaria. Madrid

    PRINCIPAL INVESTIGATOR

  • Jesús Martín-Fernández, MD Phd

    Gerencia Atención Primaria. Madrid

    PRINCIPAL INVESTIGATOR

  • Sofía Garrido-Elustondo, MD

    Gerencia Atención Primaria. Madrid

    PRINCIPAL INVESTIGATOR

  • Esperanza Escortell-Mayor, MD Phd

    Gerencia Atención Primaria. Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2011

First Posted

November 22, 2011

Study Start

July 1, 2014

Primary Completion

November 28, 2017

Study Completion

November 28, 2017

Last Updated

November 29, 2017

Record last verified: 2017-11

Locations

ES(1)