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Oral/Intramuscular B12 to Treat Cobalamin Deficiency (OB12)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01476007
First Posted: November 22, 2011
Last Update Posted: October 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Esperanza Escortell, Gerencia de Atención Primaria, Madrid
  Purpose

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.


Condition Intervention
Vitamin B 12 Deficiency Drug: oral Cobalamin (vitamin B12) Drug: intramuscular Cobalamin (vitamin B12)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Esperanza Escortell, Gerencia de Atención Primaria, Madrid:

Primary Outcome Measures:
  • Change from Cobalamin level standardization [ Time Frame: 1 year ]
    Change from Baseline in Cobalamin level at 52 weeks


Estimated Enrollment: 284
Actual Study Start Date: July 2014
Estimated Study Completion Date: December 30, 2017
Estimated Primary Completion Date: November 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oral Cobalamin (vitamin B12)
oral Cobalamin (vitamin B12)
Drug: oral Cobalamin (vitamin B12)
Intervention group: oral Optovite® B12 1000 gammas.
Other Name: Optovite®
Experimental: intramuscular Cobalamin (vitamin B12)
intramuscular Cobalamin (vitamin B12)
Drug: intramuscular Cobalamin (vitamin B12)
Control group: intramuscular Optovite® B12 1000 gammas.
Other Name: Optovite® (intramuscular)

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 ...
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01476007


Locations
Spain
Gerencia Atención Primaria, Madrid
Madrid, Spain, 28035
Sponsors and Collaborators
Gerencia de Atención Primaria, Madrid
Instituto de Salud Carlos III
Investigators
Principal Investigator: Rosario Riesgo, MD Gerencia Atención Primaria. Madrid
Study Director: Teresa Sanz-Cuesta, MD Gerencia Atención Primaria. Madrid
Principal Investigator: 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
  More Information

Publications:
Responsible Party: Esperanza Escortell, Principal Investigator, Gerencia de Atención Primaria, Madrid
ClinicalTrials.gov Identifier: NCT01476007     History of Changes
Other Study ID Numbers: 2010-024129-20
EC10-(115, 116, 117,119, 122) ( Other Grant/Funding Number: Ministerio de Sanidad y Política Social )
First Submitted: November 15, 2011
First Posted: November 22, 2011
Last Update Posted: October 10, 2017
Last Verified: October 2017

Keywords provided by Esperanza Escortell, Gerencia de Atención Primaria, Madrid:
primary health care
Vitamin B 12 Deficiency

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin B 12
Hydroxocobalamin
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics