Assessing the Efficacy of Different Carrier Systems in Oral Vitamin B12 Supplementation
NCT ID: NCT06376591
Last Updated: 2024-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2024-04-12
2024-07-14
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Sucrosomial® B12 (Center 1)
Participants will receive an oral single dose of 1000 mcg Sucrosomial® B12 supplement for 7 days.
Vit B12
Sucrosomial® B12
B-SUB® B12 (Center 1)
Participants will receive oral single dose of 1000 mcg B-SUB® B12 supplement for 7 days.
Vit B12
B-SUB® B12
Sucrosomial® B12 (Center 2)
Participants will receive an oral single dose of 1000 mcg Sucrosomial® B12 supplement for 7 days.
Vit B12
Sucrosomial® B12
Mecogen SL® B12 (Center 2)
Participants will receive an oral single dose of 1000 mcg Mecogen SL® B12 supplement for 7 days.
Vit B12
Mecogen SL® B12
Sucrosomial® B12 (Center 3)
Participants will receive an oral single dose of 1000 mcg Sucrosomial® B12 supplement for 7 days.
Vit B12
Sucrosomial® B12
Evermin® B12 (Center 3)
Participants will receive an oral single dose of 1000 mcg Evermin® B12 supplement for 7 days.
Vit B12
Evermin® B12
Neuromax® B12 (Center 3)
Participants will receive an oral single dose of 1000 mcg Neuromax® B12 supplement for 7 days.
Vit B12
Neuromax® B12
Interventions
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Vit B12
Sucrosomial® B12
Vit B12
B-SUB® B12
Vit B12
Mecogen SL® B12
Vit B12
Evermin® B12
Vit B12
Neuromax® B12
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* 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
18 Years
45 Years
ALL
Yes
Sponsors
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Liaquat University of Medical & Health Sciences
OTHER
Responsible Party
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Dr. Amjad Khan
Professor of Clinical Biochemistry and Experimental Medicine
Locations
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Liaquat University of Medical and Health Sciences
Jamshoro, , Pakistan
Countries
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References
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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.
Other Identifiers
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No. LUMHS/REC/-291
Identifier Type: -
Identifier Source: org_study_id
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