Assessing the Efficacy of Different Carrier Systems in Oral Vitamin B12 Supplementation

NCT ID: NCT06376591

Last Updated: 2024-07-18

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-12

Study Completion Date

2024-07-14

Brief Summary

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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.

Detailed Description

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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

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Vitamin B 12 Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

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.

Group Type EXPERIMENTAL

Vit B12

Intervention Type DIETARY_SUPPLEMENT

Sucrosomial® B12

B-SUB® B12 (Center 1)

Participants will receive oral single dose of 1000 mcg B-SUB® B12 supplement for 7 days.

Group Type ACTIVE_COMPARATOR

Vit B12

Intervention Type DIETARY_SUPPLEMENT

B-SUB® B12

Sucrosomial® B12 (Center 2)

Participants will receive an oral single dose of 1000 mcg Sucrosomial® B12 supplement for 7 days.

Group Type EXPERIMENTAL

Vit B12

Intervention Type DIETARY_SUPPLEMENT

Sucrosomial® B12

Mecogen SL® B12 (Center 2)

Participants will receive an oral single dose of 1000 mcg Mecogen SL® B12 supplement for 7 days.

Group Type ACTIVE_COMPARATOR

Vit B12

Intervention Type DIETARY_SUPPLEMENT

Mecogen SL® B12

Sucrosomial® B12 (Center 3)

Participants will receive an oral single dose of 1000 mcg Sucrosomial® B12 supplement for 7 days.

Group Type EXPERIMENTAL

Vit B12

Intervention Type DIETARY_SUPPLEMENT

Sucrosomial® B12

Evermin® B12 (Center 3)

Participants will receive an oral single dose of 1000 mcg Evermin® B12 supplement for 7 days.

Group Type ACTIVE_COMPARATOR

Vit B12

Intervention Type DIETARY_SUPPLEMENT

Evermin® B12

Neuromax® B12 (Center 3)

Participants will receive an oral single dose of 1000 mcg Neuromax® B12 supplement for 7 days.

Group Type ACTIVE_COMPARATOR

Vit B12

Intervention Type DIETARY_SUPPLEMENT

Neuromax® B12

Interventions

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Vit B12

Sucrosomial® B12

Intervention Type DIETARY_SUPPLEMENT

Vit B12

B-SUB® B12

Intervention Type DIETARY_SUPPLEMENT

Vit B12

Mecogen SL® B12

Intervention Type DIETARY_SUPPLEMENT

Vit B12

Evermin® B12

Intervention Type DIETARY_SUPPLEMENT

Vit B12

Neuromax® B12

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Liaquat University of Medical & Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Dr. Amjad Khan

Professor of Clinical Biochemistry and Experimental Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Liaquat University of Medical and Health Sciences

Jamshoro, , Pakistan

Site Status

Countries

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Pakistan

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.

Reference Type DERIVED
PMID: 39582666 (View on PubMed)

Other Identifiers

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No. LUMHS/REC/-291

Identifier Type: -

Identifier Source: org_study_id

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