Oral/Intramuscular B12 to Treat Cobalamin Deficiency (OB12)
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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) |
- 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: | June 2013 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2014 (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 |
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| Contact: Esperanza Escortell, Epidemiology | 34 91 3352569 | eescortell.gapm03@salud.madrid.org |
| Contact: Rosario Riesgo, Epidemiology | 34 91 6956672 | rriesgo.gapm0@salud.madrid.org |
| Spain | |
| Gerencia Atención Primaria, Madrid | Not yet recruiting |
| Madrid, Spain, 28803 | |
| Contact: Rosario Riesgo, Epidemiology 34 91 6956672 rriesgo.gapm01@salud.madrid.org | |
| Contact: Esperanza Escortell, Epidemiology 34 913352569 eescortell.gapm03@salud.madrid.org | |
| 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: | April 24, 2013 |
| 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 Vitamin B Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Hydroxocobalamin Vitamin B 12 Vitamin B Complex |
Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013