Hypovitaminosis b 12Phase 3NCT06966856
This Randomized, Clinical Trial Evaluates the Efficacy of Oral Versus Sublingual Vitamin B12 Supplementation in Correcting Early-onset Vitamin B12 Deficiency in Adult Patients Using Proton Pump Inhibitors (PPIs). The Primary Outcome is the Change in Serum Vitamin B12 Levels Over a 6-week
A Phase 3 study testing Cyanocobalamin 1000 Mcg Oral Tablet, Cyanocobalamin 1000 Mcg Sublingual Tablet and Proton Pump Inhibitor therapy only in people with Hypovitaminosis b 12, run by Tanta University.
Trial summary
This randomized, clinical trial evaluates the efficacy of oral versus sublingual vitamin B12 supplementation in correcting early-onset vitamin B12 deficiency in adult patients using proton pump inhibitors (PPIs). The primary outcome is the change in serum vitamin B12 levels over a 6-week treatment period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypovitaminosis b 12
- What is being tested?
- Cyanocobalamin 1000 Mcg Oral Tablet, Cyanocobalamin 1000 Mcg Sublingual Tablet and Proton Pump Inhibitor therapy only
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2026to 30 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-70.
- PPI use for 1-6 months (new users).
- Serum B12 between 150-300 pg/mL.
- No known prior B12 supplementation.
Who cannot join
- History of long-term GI disease (e.g., Crohn's, celiac).
- Previous gastrectomy/bariatric surgery.
- Baseline anemia with hemoglobin <9 g/dL.
- Severe renal or liver failure.
About this study
Official title: Sublingual Versus Oral Vitamin B12 for Acute Hypovitaminosis B12 Secondary to Proton Pump Inhibitors: A Prospective Randomized Study
This randomized, clinical trial evaluates the efficacy of oral versus sublingual vitamin B12 supplementation in correcting early-onset vitamin B12 deficiency in adult patients using proton pump inhibitors (PPIs). The primary outcome is the change in serum vitamin B12 levels over a 6-week treatment period. Secondary outcomes include changes in homocysteine levels, hemoglobin levels, and patient-reported satisfaction.
- Conditions
- Hypovitaminosis b 12
- Being tested
- Cyanocobalamin 1000 Mcg Oral Tablet, Cyanocobalamin 1000 Mcg Sublingual Tablet, Proton Pump Inhibitor therapy only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyanocobalamin 1000 Mcg Oral TabletDrug
Also called Vitamin B12 tablet (oral)
Oral cyanocobalamin supplement administered as a 1000 mcg tablet taken once daily for 6 weeks. Used in patients with early-onset B12 deficiency during PPI therapy.
Cyanocobalamin 1000 Mcg Sublingual TabletDrug
Also called Sublingual vitamin B12, B12 lozenge, Methylcobalamin sublingual
Sublingual cyanocobalamin supplement administered as a 1000 mcg tablet placed under the tongue once daily for 6 weeks. Used in patients with early-onset B12 deficiency during PPI therapy.
Proton Pump Inhibitor therapy onlyOther
Also called PPI, omeprazole, esomeprazole, pantoprazole
This group will continue their standard PPI therapy without receiving any vitamin B12 supplementation, serving as a control group for the comparison of B12 correction efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Oral Vitamin B12 Group | Experimental | Participants in this arm will receive 1000 mcg oral cyanocobalamin daily for 6 weeks. The supplement will be administered as a swallowed tablet. Patients will continue their regular PPI therapy during the study period. Receives: Drug: Cyanocobalamin 1000 Mcg Oral Tablet |
| Sublingual Vitamin B12 Group | Experimental | Participants in this arm will receive 1000 mcg sublingual cyanocobalamin daily for 6 weeks. The supplement will be administered as a sublingual tablet placed under the tongue. Patients will continue their regular PPI therapy during the study period. Receives: Drug: Cyanocobalamin 1000 Mcg Sublingual Tablet |
| Control Group (PPI Only) | Active comparator | Participants in this arm will continue their regular PPI therapy without receiving vitamin B12 supplementation. This arm serves as a control to evaluate natural changes in B12 levels without supplementation. Receives: Other: Proton Pump Inhibitor therapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Vitamin B12 Concentration
Measurement of serum vitamin B12 levels before and after 6 weeks of intervention to assess the efficacy of oral versus sublingual supplementation.
Measured: Baseline and Week 6
Secondary outcomes (3)
Change in Plasma Homocysteine Level
Plasma homocysteine levels will be measured at baseline and at 6 weeks to assess the functional improvement in vitamin B12 status.
Measured: Baseline and Week 6
Change in Hemoglobin Level
To assess improvement in anemia, hemoglobin concentration will be measured at baseline and at 6 weeks.
Measured: Baseline and Week 6
Patient-Reported Satisfaction with Route of Supplementation
At the end of the study, patients will be surveyed about their satisfaction and ease of use with the assigned supplementation route (oral or sublingual).
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start30 Dec 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypovitaminosis b 12Studies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Alaa Abdel Samie, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966856
- Sponsor's protocol ID
- ORSUB12
- Status last verified
- May 2025
- First submitted
- 4 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Versus Oral Vitamin B12 for Acute Hypovitaminosis B12 Secondary to Proton Pump Inhibitors: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06966856
- Acronym / sponsor ID
- ORSUB12
- Conditions
- Hypovitaminosis b 12
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 13 May 2025 (actual)
- 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.
This randomized, clinical trial evaluates the efficacy of oral versus sublingual vitamin B12 supplementation in correcting early-onset vitamin B12 deficiency in adult patients using proton pump inhibitors (PPIs). The primary outcome is the change in serum vitamin B12 levels over a 6-week treatment period. Secondary outcomes include changes in homocysteine levels, hemoglobin levels, and patient-reported satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Vitamin B12 Group | Experimental | Drug: Cyanocobalamin 1000 Mcg Oral TabletParticipants in this arm will receive 1000 mcg oral cyanocobalamin daily for 6 weeks. The supplement will be administered as a swallowed tablet. Patients will continue their regular PPI therapy during the study period. |
| Sublingual Vitamin B12 Group | Experimental | Drug: Cyanocobalamin 1000 Mcg Sublingual TabletParticipants in this arm will receive 1000 mcg sublingual cyanocobalamin daily for 6 weeks. The supplement will be administered as a sublingual tablet placed under the tongue. Patients will continue their regular PPI therapy during the study period. |
| Control Group (PPI Only) | Active comparator | Other: Proton Pump Inhibitor therapy onlyParticipants in this arm will continue their regular PPI therapy without receiving vitamin B12 supplementation. This arm serves as a control to evaluate natural changes in B12 levels without supplementation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-70.
- PPI use for 1-6 months (new users).
- Serum B12 between 150-300 pg/mL.
- No known prior B12 supplementation.
Key exclusion criteria (4 listed)
- History of long-term GI disease (e.g., Crohn's, celiac).
- Previous gastrectomy/bariatric surgery.
- Baseline anemia with hemoglobin <9 g/dL.
- Severe renal or liver failure.
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 |
|---|---|---|
| Cyanocobalamin 1000 Mcg Oral TabletAlso: Vitamin B12 tablet (oral)Oral cyanocobalamin supplement administered as a 1000 mcg tablet taken once daily for 6 weeks. Used in patients with early-onset B12 deficiency during PPI therapy. | Drug | Oral Vitamin B12 Group |
| Cyanocobalamin 1000 Mcg Sublingual TabletAlso: Sublingual vitamin B12, B12 lozenge, Methylcobalamin sublingualSublingual cyanocobalamin supplement administered as a 1000 mcg tablet placed under the tongue once daily for 6 weeks. Used in patients with early-onset B12 deficiency during PPI therapy. | Drug | Sublingual Vitamin B12 Group |
| Proton Pump Inhibitor therapy onlyAlso: PPI, omeprazole, esomeprazole, pantoprazoleThis group will continue their standard PPI therapy without receiving any vitamin B12 supplementation, serving as a control group for the comparison of B12 correction efficacy. | Other | Control Group (PPI Only) |
Primary outcome
Change in Serum Vitamin B12 Concentration
Time frame: Baseline and Week 6
Measurement of serum vitamin B12 levels before and after 6 weeks of intervention to assess the efficacy of oral versus sublingual supplementation.
3 secondary outcomes
Change in Plasma Homocysteine Level
Time frame: Baseline and Week 6
Change in Hemoglobin Level
Time frame: Baseline and Week 6
Patient-Reported Satisfaction with Route of Supplementation
Time frame: Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cyanocobalamin 1000 Mcg Oral Tablet, Cyanocobalamin 1000 Mcg Sublingual Tablet and Proton Pump Inhibitor therapy only in people with Hypovitaminosis b 12, run by Tanta University.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 in Serum Vitamin B12 Concentration (time frame: Baseline and Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.