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

July 16, 2024 updated by: Dr. Amjad Khan, Liaquat University of Medical & Health Sciences

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Jamshoro, Pakistan, 76090
        • Liaquat University of Medical and Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sucrosomial® B12 (Center 1)
Participants will receive an oral single dose of 1000 mcg Sucrosomial® B12 supplement for 7 days.
Dietary supplement: Vit B12
Sucrosomial® B12
Dietary supplement: Vit B12
B-SUB® B12
Dietary supplement: Vit B12
Mecogen SL® B12
Dietary supplement: Vit B12
Evermin® B12
Dietary supplement: Vit B12
Neuromax® B12
Active Comparator: B-SUB® B12 (Center 1)
Participants will receive oral single dose of 1000 mcg B-SUB® B12 supplement for 7 days.
Dietary supplement: Vit B12
Sucrosomial® B12
Dietary supplement: Vit B12
B-SUB® B12
Dietary supplement: Vit B12
Mecogen SL® B12
Dietary supplement: Vit B12
Evermin® B12
Dietary supplement: Vit B12
Neuromax® B12
Experimental: Sucrosomial® B12 (Center 2)
Participants will receive an oral single dose of 1000 mcg Sucrosomial® B12 supplement for 7 days.
Dietary supplement: Vit B12
Sucrosomial® B12
Dietary supplement: Vit B12
B-SUB® B12
Dietary supplement: Vit B12
Mecogen SL® B12
Dietary supplement: Vit B12
Evermin® B12
Dietary supplement: Vit B12
Neuromax® B12
Active Comparator: Mecogen SL® B12 (Center 2)
Participants will receive an oral single dose of 1000 mcg Mecogen SL® B12 supplement for 7 days.
Dietary supplement: Vit B12
Sucrosomial® B12
Dietary supplement: Vit B12
B-SUB® B12
Dietary supplement: Vit B12
Mecogen SL® B12
Dietary supplement: Vit B12
Evermin® B12
Dietary supplement: Vit B12
Neuromax® B12
Experimental: Sucrosomial® B12 (Center 3)
Participants will receive an oral single dose of 1000 mcg Sucrosomial® B12 supplement for 7 days.
Dietary supplement: Vit B12
Sucrosomial® B12
Dietary supplement: Vit B12
B-SUB® B12
Dietary supplement: Vit B12
Mecogen SL® B12
Dietary supplement: Vit B12
Evermin® B12
Dietary supplement: Vit B12
Neuromax® B12
Active Comparator: Evermin® B12 (Center 3)
Participants will receive an oral single dose of 1000 mcg Evermin® B12 supplement for 7 days.
Dietary supplement: Vit B12
Sucrosomial® B12
Dietary supplement: Vit B12
B-SUB® B12
Dietary supplement: Vit B12
Mecogen SL® B12
Dietary supplement: Vit B12
Evermin® B12
Dietary supplement: Vit B12
Neuromax® B12
Active Comparator: Neuromax® B12 (Center 3)
Participants will receive an oral single dose of 1000 mcg Neuromax® B12 supplement for 7 days.
Dietary supplement: Vit B12
Sucrosomial® B12
Dietary supplement: Vit B12
B-SUB® B12
Dietary supplement: Vit B12
Mecogen SL® B12
Dietary supplement: Vit B12
Evermin® B12
Dietary supplement: Vit B12
Neuromax® B12

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Supplementation effect on circulatory vitamin B12 levels
Time Frame: Day 1, Day 3, Day 5, Day 7
Changes in serum vitamin B12 levels
Day 1, Day 3, Day 5, Day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Effects
Time Frame: one-week
Number of participants report treatment-emergent adverse effects
one-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Liaquat University of Medical & Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 7, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 14, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • No. LUMHS/REC/-291

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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