Vitamin B 12 DeficiencyNCT06376591
Assessing the Efficacy of Different Carrier Systems in Oral Vitamin B12 Supplementation
A study testing Vit B12 in people with Vitamin B 12 Deficiency, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.
Trial summary
Vitamin B12, a vital nutrient, plays a crucial role in red blood cell formation, neurological function, and DNA synthesis. Deficiency in B12 can lead to anemia, neurological symptoms such as tingling or numbness, and cognitive impairment. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin B 12 Deficiency
- What is being tested?
- Vit B12
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Apr 2024to 14 Jul 2024
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults, male or female, Aged 18 to 45 years
- Stable medical conditions, including stable cardiovascular, renal, hepatic, and hematological status,
- Normal vital signs Body mass index (BMI) 18-30 kg/m2
- Suboptimal vitamin B12 status, defined as serum B12 levels within the lower end of the reference range established by the laboratory conducting the assay.
- Willing and able to provide informed written consent.
- Able to comply with study procedures and follow-up visits as outlined in the protocol.
Who cannot join
- Known hypersensitivity or allergy to vitamin B12 or any of its components
- Known history of cobalt allergy or sensitivity.
- Severe malabsorption syndromes, including pernicious anemia or intestinal disorders affecting vitamin B12 absorption
- History of gastric bypass surgery or other procedures that significantly alter gastrointestinal anatomy or function
- Significant renal impairment (eGFR < 30 mL/min/1.73m²) or hepatic impairment
- Cancer
Show all 12Show fewer
- Uncontrolled or significant cardiovascular disease, including recent myocardial infarction, unstable angina, or heart failure
- History of psychiatric illness or cognitive impairment that may impair their ability to comply with study procedures or provide informed consent
- Currently enrolled in another clinical trial involving investigational products or interventions.
- Pregnant or breast-feeding women
- Current use of acetaminophen, or nonsteroidal anti-inflammatory drugs, antibiotics, antacids, PPIs, multivitamins, or nutritional supplements with Vit B12
- Any other medical condition or circumstance that, in the investigator's judgment, would compromise the safety of the participant or the integrity of the study
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Liaquat University of Medical and Health Sciences
Jamshoro, 76090
About this study
Official title: Assessing the Efficacy of Different Carrier Systems in Oral Vitamin B12 Supplementation in Improving Circulatory B12 Levels in Healthy Adults
Vitamin B12, a vital nutrient, plays a crucial role in red blood cell formation, neurological function, and DNA synthesis. Deficiency in B12 can lead to anemia, neurological symptoms such as tingling or numbness, and cognitive impairment. Oral B12 supplementation serves as an effective strategy to address B12 deficiency, especially for individuals with limited dietary intake or absorption issues. Regular B12 supplementation can help restore body B12 levels, alleviate deficiency-related symptoms, and support overall health and well-being.
Read the detailed description
The carrier system in oral vitamin B12 supplements plays a pivotal role in ensuring the stability and efficacy of the supplement. It helps protect the vitamin from degradation in the acidic environment of the stomach, enhancing its bioavailability. Additionally, the carrier system facilitates the transport of vitamin B12 across the gastrointestinal tract, promoting optimal absorption. By optimizing the delivery of B12 to the small intestine, the carrier system maximizes its potential for absorption into the bloodstream. Overall, the choice of carrier system significantly impacts the effectiveness of oral B12 supplementation in addressing deficiency and improving health outcomes.
Limited research exists regarding the exploration of various carrier systems used in oral B12 supplementation. This gap hinders a comprehensive understanding of how different carriers affect B12 absorption and efficacy. Further studies are needed to elucidate the optimal carrier system for maximizing B12 bioavailability and improving clinical outcomes. Expanding research in this area can enhance our knowledge and guide the development of more effective oral B12 supplements.
This study aims to compare the efficacy of sucrosomial and non-sucrosomial carrier systems in delivering vitamin B12 orally. By assessing absorption kinetics and clinical outcomes, we seek to determine the superiority of the sucrosomial carrier system in enhancing B12 bioavailability. Insights from this research could help in the development of more effective oral B12 supplements.
- Conditions
- Vitamin B 12 Deficiency
- Being tested
- Vit B12
- 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.
Vit B12Dietary supplement
Sucrosomial® B12
Vit B12Dietary supplement
B-SUB® B12
Vit B12Dietary supplement
Mecogen SL® B12
Vit B12Dietary supplement
Evermin® B12
Vit B12Dietary supplement
Neuromax® B12
| Study group | Role | What they receive |
|---|---|---|
| Sucrosomial® B12 (Center 1) | Experimental | Participants will receive an oral single dose of 1000 mcg Sucrosomial® B12 supplement for 7 days. Receives: Dietary Supplement: Vit B12 |
| B-SUB® B12 (Center 1) | Active comparator | Participants will receive oral single dose of 1000 mcg B-SUB® B12 supplement for 7 days. Receives: Dietary Supplement: Vit B12 |
| Sucrosomial® B12 (Center 2) | Experimental | Participants will receive an oral single dose of 1000 mcg Sucrosomial® B12 supplement for 7 days. Receives: Dietary Supplement: Vit B12 |
| Mecogen SL® B12 (Center 2) | Active comparator | Participants will receive an oral single dose of 1000 mcg Mecogen SL® B12 supplement for 7 days. Receives: Dietary Supplement: Vit B12 |
| Sucrosomial® B12 (Center 3) | Experimental | Participants will receive an oral single dose of 1000 mcg Sucrosomial® B12 supplement for 7 days. Receives: Dietary Supplement: Vit B12 |
| Evermin® B12 (Center 3) | Active comparator | Participants will receive an oral single dose of 1000 mcg Evermin® B12 supplement for 7 days. Receives: Dietary Supplement: Vit B12 |
| Neuromax® B12 (Center 3) | Active comparator | Participants will receive an oral single dose of 1000 mcg Neuromax® B12 supplement for 7 days. Receives: Dietary Supplement: Vit B12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supplementation effect on circulatory vitamin B12 levels
Changes in serum vitamin B12 levels
Measured: Day 1, Day 3, Day 5, Day 7
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Effects
Number of participants report treatment-emergent adverse effects
Measured: one-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start12 Apr 2024
- Primary completion7 Jul 2024
- Study completion14 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376591
- Sponsor's protocol ID
- No. LUMHS/REC/-291
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Memon NM, Conti G, Brilli E, Tarantino G, Chaudhry MNA, Baloch A, Shafiq A, Mumtaz SU, Qaisar W, Iqtadar S, Abrar S, Kanwal A, Akhtar MH, Latif H, Rabbani F, Ujjan ID, Turroni S, Khan A. Comparative bioavailability study of supplemental oral Sucrosomial (R) vs. oral conventional vitamin B12 in enhancing circulatory B12 levels in healthy deficient adults: a multicentre, double-blind randomized clinical trial. Front Nutr. 2024 Nov 8;11:1493593. doi: 10.3389/fnut.2024.1493593. eCollection 2024.
PubMed 39582666
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Different Carrier Systems in Oral Vitamin B12 Supplementation in Improving Circulatory B12 Levels in Healthy Adults
- ClinicalTrials.gov ID
- NCT06376591
- Acronym / sponsor ID
- No. LUMHS/REC/-291
- Conditions
- Vitamin B 12 Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 7 Jul 2024 (actual)
- Study completion
- 14 Jul 2024 (actual)
- First posted
- 19 Apr 2024 (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.
Vitamin B12, a vital nutrient, plays a crucial role in red blood cell formation, neurological function, and DNA synthesis. Deficiency in B12 can lead to anemia, neurological symptoms such as tingling or numbness, and cognitive impairment. Oral B12 supplementation serves as an effective strategy to address B12 deficiency, especially for individuals with limited dietary intake or absorption issues. Regular B12 supplementation can help restore body B12 levels, alleviate deficiency-related symptoms, and support overall health and well-being.
Detailed description
The carrier system in oral vitamin B12 supplements plays a pivotal role in ensuring the stability and efficacy of the supplement. It helps protect the vitamin from degradation in the acidic environment of the stomach, enhancing its bioavailability. Additionally, the carrier system facilitates the transport of vitamin B12 across the gastrointestinal tract, promoting optimal absorption. By optimizing the delivery of B12 to the small intestine, the carrier system maximizes its potential for absorption into the bloodstream. Overall, the choice of carrier system significantly impacts the effectiveness of oral B12 supplementation in addressing deficiency and improving health outcomes.
Limited research exists regarding the exploration of various carrier systems used in oral B12 supplementation. This gap hinders a comprehensive understanding of how different carriers affect B12 absorption and efficacy. Further studies are needed to elucidate the optimal carrier system for maximizing B12 bioavailability and improving clinical outcomes. Expanding research in this area can enhance our knowledge and guide the development of more effective oral B12 supplements.
This study aims to compare the efficacy of sucrosomial and non-sucrosomial carrier systems in delivering vitamin B12 orally. By assessing absorption kinetics and clinical outcomes, we seek to determine the superiority of the sucrosomial carrier system in enhancing B12 bioavailability. Insights from this research could help in the development of more effective oral B12 supplements.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Sucrosomial® B12 (Center 1) | Experimental | Dietary Supplement: Vit B12Participants will receive an oral single dose of 1000 mcg Sucrosomial® B12 supplement for 7 days. |
| B-SUB® B12 (Center 1) | Active comparator | Dietary Supplement: Vit B12Participants will receive oral single dose of 1000 mcg B-SUB® B12 supplement for 7 days. |
| Sucrosomial® B12 (Center 2) | Experimental | Dietary Supplement: Vit B12Participants will receive an oral single dose of 1000 mcg Sucrosomial® B12 supplement for 7 days. |
| Mecogen SL® B12 (Center 2) | Active comparator | Dietary Supplement: Vit B12Participants will receive an oral single dose of 1000 mcg Mecogen SL® B12 supplement for 7 days. |
| Sucrosomial® B12 (Center 3) | Experimental | Dietary Supplement: Vit B12Participants will receive an oral single dose of 1000 mcg Sucrosomial® B12 supplement for 7 days. |
| Evermin® B12 (Center 3) | Active comparator | Dietary Supplement: Vit B12Participants will receive an oral single dose of 1000 mcg Evermin® B12 supplement for 7 days. |
| Neuromax® B12 (Center 3) | Active comparator | Dietary Supplement: Vit B12Participants will receive an oral single dose of 1000 mcg Neuromax® B12 supplement for 7 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adults, male or female, Aged 18 to 45 years
- Stable medical conditions, including stable cardiovascular, renal, hepatic, and hematological status,
- Normal vital signs Body mass index (BMI) 18-30 kg/m2
- Suboptimal vitamin B12 status, defined as serum B12 levels within the lower end of the reference range established by the laboratory conducting the assay.
- Willing and able to provide informed written consent.
Key exclusion criteria (12 listed)
- Known hypersensitivity or allergy to vitamin B12 or any of its components
- Known history of cobalt allergy or sensitivity.
- Severe malabsorption syndromes, including pernicious anemia or intestinal disorders affecting vitamin B12 absorption
- History of gastric bypass surgery or other procedures that significantly alter gastrointestinal anatomy or function
- Significant renal impairment (eGFR < 30 mL/min/1.73m²) or hepatic impairment
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 |
|---|---|---|
| Vit B12Sucrosomial® B12 | Dietary supplement | Sucrosomial® B12 (Center 1), Sucrosomial® B12 (Center 2), Sucrosomial® B12 (Center 3) |
| Vit B12B-SUB® B12 | Dietary supplement | B-SUB® B12 (Center 1) |
| Vit B12Mecogen SL® B12 | Dietary supplement | Mecogen SL® B12 (Center 2) |
| Vit B12Evermin® B12 | Dietary supplement | Evermin® B12 (Center 3) |
| Vit B12Neuromax® B12 | Dietary supplement | Neuromax® B12 (Center 3) |
Primary outcome
Supplementation effect on circulatory vitamin B12 levels
Time frame: Day 1, Day 3, Day 5, Day 7
Changes in serum vitamin B12 levels
1 secondary outcome
Incidence of Treatment-Emergent Adverse Effects
Time frame: one-week
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 18 Jul 2024.
- Derived from this study: PubMed 39582666Memon NM, Conti G, Brilli E, Tarantino G, Chaudhry MNA, Baloch A, Shafiq A, Mumtaz SU, Qaisar W, Iqtadar S, Abrar S, Kanwal A, Akhtar MH, Latif H, Rabbani F, Ujjan ID, Turroni S, Khan A. Comparative bioavailability study of supplemental oral Sucrosomial (R) vs. oral conventional vitamin B12 in enhancing circulatory B12 levels in healthy deficient adults: a multicentre, double-blind randomized clinical trial. Front Nutr. 2024 Nov 8;11:1493593. doi: 10.3389/fnut.2024.1493593. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vit B12 in people with Vitamin B 12 Deficiency, run by Liaquat University of Medical & Health Sciences at 1 site in Pakistan.
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 6 inclusion and 12 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 18 Jul 2024. 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 Pakistan. 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?
Supplementation effect on circulatory vitamin B12 levels (time frame: Day 1, Day 3, Day 5, Day 7). 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 NCT06376591, which also lists 1 linked publication.
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 18 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.