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| ID | Type | Description | Link |
|---|---|---|---|
| EC10-(115, 116, 117,119, 122) | Other Grant/Funding Number | Ministerio de Sanidad y Política Social |
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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral Cobalamin (vitamin B12) | Experimental | oral Cobalamin (vitamin B12) |
|
| intramuscular Cobalamin (vitamin B12) | Experimental | intramuscular Cobalamin (vitamin B12) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral Cobalamin (vitamin B12) | Drug | Intervention group: oral Optovite® B12 1000 gammas. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Cobalamin level standardization | Change from Baseline in Cobalamin level at 52 weeks | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gerencia Atención Primaria, Madrid | Madrid | 28035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22650964 | Background | 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. | |
| 32819927 |
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| ID | Term |
|---|---|
| D014806 | Vitamin B 12 Deficiency |
| ID | Term |
|---|---|
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
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| ID | Term |
|---|---|
| D014805 | Vitamin B 12 |
| D007273 | Injections, Intramuscular |
| ID | Term |
|---|---|
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
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| intramuscular Cobalamin (vitamin B12) | Drug | Control group: intramuscular Optovite® B12 1000 gammas. |
|
|
| Derived |
| 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. |
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |