Trial reportBMJ open2020
Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care: a pragmatic, randomised, non-inferiority clinical trial (OB12).
Trial report in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01476007 (Oral Versus Intramuscular Cobalamin to Treat Cobalamin Deficiency), which is not on this map. Cited by 21 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Oral Versus Intramuscular Cobalamin to Treat Cobalamin Deficiency: Noninferiority Randomised Controlled Trial Pragmatic and Multi-center in the Primary Healthcare Setting (OB12 Project)
Who cites it
21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 61 citations in OpenAlex.
- Efficacy of sublingual and oral vitamin B12 versus intramuscular administration: insights from a systematic review and meta-analysis.Frontiers in pharmacology · 2025Pooled it
- Efficacy of different routes of vitamin B12 supplementation for the treatment of patients with vitamin B12 deficiency: A systematic review and network meta-analysis.Irish journal of medical science · 2024Pooled it
- Vitamin B12 replacement strategies: a Brazilian delphi consensus.EClinicalMedicine · 2026Article
- Comparative efficacy of vitamin B12 supplementation routes in adults with replacement indication: a systematic review.EClinicalMedicine · 2026Review
- The Dynamic Coenzyme Network of B Vitamins in Nutritional Neuropathy and Neuropsychiatric Vulnerability: A Mechanistic Narrative Review.Nutrients · 2026Review
- Vitamin B12 Deficiency Presenting as Anemia and Functional Decline in an Older Adult: A Case Report.Cureus · 2026Article
- Oral capsule administration of biomacromolecules that achieves bioavailability and pharmacokinetics comparable to subcutaneous injection in dogs - the BIONDDDrug delivery and translational research · 2026Article
- Vitamin B12 and Reproductive Health: Clinical Insights, Emerging Mechanistic Understanding, and Nutritional Aspects.Molecular reproduction and development · 2026Review
- Elevated serum cobalamin levels in childhood: a retrospective analysis.BMC pediatrics · 2025Article
- Vitamin B12 in Cancer Patients: Clinical Insights into Deficiency, Excess, Diagnosis, and Management.Nutrients · 2025Review
- Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion · 2025Review
- Unraveling the Enigma: Food Cobalamin Malabsorption and the Persistent Shadow of Cobalamin Deficiency.Journal of clinical medicine · 2025Review
- Desensitization for Vitamin B12 Hypersensitivity and How to Do It.Biomedicines · 2025Review
- A Framework to Guide Defining an Upper Threshold of Crystalline Vitamin B12 in Foods and Food Supplements.Current nutrition reports · 2025Review
- Article
- Diagnosis, Treatment and Long-Term Management of Vitamin B12 Deficiency in Adults: A Delphi Expert Consensus.Journal of clinical medicine · 2024Article
- Points to Consider in Health Assessment of Adult Patients with Primary Antibody Deficiencies.Journal of clinical medicine · 2023Article
- Vitamin BMolecules (Basel, Switzerland) · 2022Review
- Inherited and acquired vitamin B12 deficiencies: Which administration route to choose for supplementation?Frontiers in pharmacology · 2022Review
- Testing and Prescribing Vitamin B12 in Swiss General Practice: A Survey among Physicians.Nutrients · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
26 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo compare the effectiveness of oral versus intramuscular (IM) vitamin B
designPragmatic, randomised, non-inferiority, multicentre trial in 22 primary healthcare centres in Madrid (Spain).
participants283 patients ≥65 years with VB12 deficiency were randomly assigned to oral (n=140) or IM (n=143) treatment arm.
interventionsThe IM arm received 1 mg VB12 on alternate days in weeks 1-2, 1 mg/week in weeks 3-8 and 1 mg/month in weeks 9-52. The oral arm received 1 mg/day in weeks 1-8 and 1 mg/week in weeks 9-52. MAIN OUTCOMES: Serum VB12 concentration normalisation (≥211 pg/mL) at 8, 26 and 52 weeks. Non-inferiority would be declared if the difference between arms is 10% or less. Secondary outcomes included symptoms, adverse events, adherence to treatment, quality of life, patient preferences and satisfaction.
resultsThe follow-up period (52 weeks) was completed by 229 patients (80.9%). At week 8, the percentage of patients in each arm who achieved normal B
conclusionsOral administration was no less effective than IM administration at 8 weeks. Although differences were found between administration routes at week 52, the probability that the differences were below the non-inferiority threshold was very low. TRIAL REGISTRATION NUMBERS: NCT01476007; EUDRACT (2010-024129-20).
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