Vitamin B 12 DeficiencyOB12NCT01476007
Oral/Intramuscular B12 to Treat Cobalamin Deficiency
A study testing oral Cobalamin (vitamin B12) and intramuscular Cobalamin (vitamin B12) in people with Vitamin B 12 Deficiency, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Vitamin B 12 Deficiency
- What is being tested?
- oral Cobalamin (vitamin B12) and intramuscular Cobalamin (vitamin B12)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2014to 28 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ≥ 65 aged patients with Cobalamin Deficiency.
- Patients give inform consent.
Who cannot join
- Treatment with B12 (1 last year)
- Neurologic or psychiatric pathologies
- Folic acid < 2.3ng/ml ...
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
Read more
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.
Read the 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.
- Conditions
- Vitamin B 12 Deficiency
- Being tested
- oral Cobalamin (vitamin B12), intramuscular Cobalamin (vitamin B12)
- Keywords
- primary health care, Vitamin B 12 Deficiency
- Medical subject headings
- Vitamin B 12 Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral Cobalamin (vitamin B12)Drug
Also called Optovite®
Intervention group: oral Optovite® B12 1000 gammas.
intramuscular Cobalamin (vitamin B12)Drug
Also called Optovite® (intramuscular)
Control group: intramuscular Optovite® B12 1000 gammas.
| Study group | Role | What they receive |
|---|---|---|
| oral Cobalamin (vitamin B12) | Experimental | oral Cobalamin (vitamin B12) Receives: Drug: oral Cobalamin (vitamin B12) |
| intramuscular Cobalamin (vitamin B12) | Experimental | intramuscular Cobalamin (vitamin B12) Receives: Drug: intramuscular Cobalamin (vitamin B12) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Cobalamin level standardization
Change from Baseline in Cobalamin level at 52 weeks
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJul 2014
- Primary completion28 Nov 2017
- Study completion28 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vitamin B 12 DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerencia de Atención Primaria, Madrid
- Sponsor type
- Other government
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Esperanza Escortell, Gerencia de Atención Primaria, Madrid
- Investigators
- Rosario Riesgo, MD, Principal investigator, Gerencia Atención Primaria. MadridTeresa Sanz-Cuesta, MD, Study director, Gerencia Atención Primaria. MadridIsabel DelCura-González, MD Phd, Principal investigator, Gerencia Atención Primaria. MadridJesús Martín-Fernández, MD Phd, Principal investigator, Gerencia Atención Primaria. MadridSofía Garrido-Elustondo, MD, Principal investigator, Gerencia Atención Primaria. MadridEsperanza Escortell-Mayor, MD Phd, Principal investigator, Gerencia Atención Primaria. Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476007
- Sponsor's protocol ID
- 2010-024129-20
- Other IDs
- EC10-(115, 116, 117,119, 122)
- Acronym
- OB12
- Status last verified
- Nov 2017
- First submitted
- 15 Nov 2011
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22650964Sanz-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.
PubMed 32819927
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01476007
- Acronym / sponsor ID
- OB12 / 2010-024129-20
- Conditions
- Vitamin B 12 Deficiency
- Keywords
- primary health care, Vitamin B 12 Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Gerencia de Atención Primaria, MadridOther government
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Jul 2014 (actual)
- Primary completion
- 28 Nov 2017 (actual)
- Study completion
- 28 Nov 2017 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral Cobalamin (vitamin B12) | Experimental | Drug: oral Cobalamin (vitamin B12)oral Cobalamin (vitamin B12) |
| intramuscular Cobalamin (vitamin B12) | Experimental | Drug: intramuscular Cobalamin (vitamin B12)intramuscular Cobalamin (vitamin B12) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- ≥ 65 aged patients with Cobalamin Deficiency.
- Patients give inform consent.
Key exclusion criteria (3 listed)
- Treatment with B12 (1 last year)
- Neurologic or psychiatric pathologies
- Folic acid < 2.3ng/ml ...
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral Cobalamin (vitamin B12)Also: Optovite®Intervention group: oral Optovite® B12 1000 gammas. | Drug | oral Cobalamin (vitamin B12) |
| intramuscular Cobalamin (vitamin B12)Also: Optovite® (intramuscular)Control group: intramuscular Optovite® B12 1000 gammas. | Drug | intramuscular Cobalamin (vitamin B12) |
Primary outcome
Change from Cobalamin level standardization
Time frame: 1 year
Change from Baseline in Cobalamin level at 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
- Background: PubMed 22650964Sanz-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.
- Derived from this study: PubMed 32819927Sanz-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosario Riesgo, MD principal investigator
Gerencia Atención Primaria. Madrid
Teresa Sanz-Cuesta, MD study director
Gerencia Atención Primaria. Madrid
Isabel DelCura-González, MD Phd principal investigator
Gerencia Atención Primaria. Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral Cobalamin (vitamin B12) and intramuscular Cobalamin (vitamin B12) in people with Vitamin B 12 Deficiency, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Cobalamin level standardization (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01476007, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2017.