Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Oral/Intramuscular B12 to Treat Cobalamin Deficiency (OB12)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Gerencia de Atención Primaria, Madrid
Sponsor:
Information provided by (Responsible Party):
Esperanza Escortell, Gerencia de Atención Primaria, Madrid
ClinicalTrials.gov Identifier:
NCT01476007
First received: November 15, 2011
Last updated: October 13, 2014
Last verified: October 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 Gerencia de Atención Primaria, Madrid:

Primary Outcome Measures:
  • Change from Cobalamin level standardization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Change from Baseline in Cobalamin level at 52 weeks


Estimated Enrollment: 320
Study Start Date: July 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: July 2015 (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) 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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Treatment with B12 (5 last years)
  • Neurologic or psychiatric pathologies
  • Folic acid < 2.3ng/ml ...
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476007

Contacts
Contact: Esperanza Escortell, Epidemiology 34 91 3352569 eescortell@salud.madrid.org
Contact: Rosario Riesgo, Epidemiology 34 91 6956672 rriesgo@salud.madrid.org

Locations
Spain
Gerencia Atención Primaria, Madrid Recruiting
Madrid, Spain, 28035
Contact: Rosario Riesgo, Epidemiology    34 91 6956672    rriesgo@salud.madrid.org   
Contact: Esperanza Escortell, Epidemiology    34 913352569    eescortell@salud.madrid.org   
Sponsors and Collaborators
Gerencia de Atención Primaria, Madrid
Investigators
Principal Investigator: Rosario Riesgo, Epidemiology Gerencia Atención Primaria. Madrid
  More Information

No publications provided by Gerencia de Atención Primaria, Madrid

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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, EC10-122
Study First Received: November 15, 2011
Last Updated: October 13, 2014
Health Authority: Spain: Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica

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

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

ClinicalTrials.gov processed this record on November 20, 2014