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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sucrosomial® B12 (Center 1) | Experimental | Participants will receive an oral single dose of 1000 mcg Sucrosomial® B12 supplement for 7 days. |
|
| B-SUB® B12 (Center 1) | Active Comparator | Participants will receive oral single dose of 1000 mcg B-SUB® B12 supplement for 7 days. |
|
| Sucrosomial® B12 (Center 2) | Experimental | Participants will receive an oral single dose of 1000 mcg Sucrosomial® B12 supplement for 7 days. |
|
| Mecogen SL® B12 (Center 2) | Active Comparator | Participants will receive an oral single dose of 1000 mcg Mecogen SL® B12 supplement for 7 days. |
|
| Sucrosomial® B12 (Center 3) | Experimental | Participants will receive an oral single dose of 1000 mcg Sucrosomial® B12 supplement for 7 days. |
|
| Evermin® B12 (Center 3) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vit B12 | Dietary Supplement | Sucrosomial® B12 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Supplementation effect on circulatory vitamin B12 levels | Changes in serum vitamin B12 levels | Day 1, Day 3, Day 5, Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Effects | Number of participants report treatment-emergent adverse effects | one-week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liaquat University of Medical and Health Sciences | Jamshoro | 76090 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39582666 | Derived | 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. |
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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 |
| ID | Term |
|---|---|
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
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| Active Comparator |
Participants will receive an oral single dose of 1000 mcg Evermin® B12 supplement for 7 days. |
|
| Neuromax® B12 (Center 3) | Active Comparator | Participants will receive an oral single dose of 1000 mcg Neuromax® B12 supplement for 7 days. |
|
| Vit B12 | Dietary Supplement | B-SUB® B12 |
|
| Vit B12 | Dietary Supplement | Mecogen SL® B12 |
|
| Vit B12 | Dietary Supplement | Evermin® B12 |
|
| Vit B12 | Dietary Supplement | Neuromax® B12 |
|
| 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 |