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CompletedNCT06376591Updated Jul 18, 2024

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

An interventional study of Vit B12 and Vit B12 in Vitamin B 12 Deficiency, sponsored by Liaquat University of Medical & Health Sciences. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-18.

Sponsored by Liaquat University of Medical & Health Sciences · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Vitamin B 12 Deficiency
03

In context

Vitamin B 12 Deficiency

72 studies on the registry are indexed under Vitamin B 12 Deficiency; 10 are open to participants now.

This study's enrollment of 70 is close to the median of 65 across 44 interventional studies indexed under Vitamin B 12 Deficiency.

Browse Vitamin B 12 Deficiency studies →

Lead sponsor

Liaquat University of Medical & Health Sciences is the lead sponsor of 55 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
70 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

  • Dietary supplementVit B12

    Sucrosomial® B12

  • Dietary supplementVit B12

    B-SUB® B12

  • Dietary supplementVit B12

    Mecogen SL® B12

  • Dietary supplementVit B12

    Evermin® B12

  • Dietary supplementVit B12

    Neuromax® B12

06

What researchers measure

Primary outcomes

  1. Supplementation effect on circulatory vitamin B12 levels

    Changes in serum vitamin B12 levels

    Time frame: 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

    Time frame: one-week

07

Study locations

1 site
  • Liaquat University of Medical and Health Sciences
    Jamshoro, 76090, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06376591
Lead sponsor
Liaquat University of Medical & Health Sciences
Responsible party
Dr. Amjad Khan (Professor of Clinical Biochemistry and Experimental Medicine, Liaquat University of Medical & Health Sciences) — Principal investigator
First posted
Apr 19, 2024
Start date
Apr 12, 2024
Primary completion
Jul 7, 2024
Completion
Jul 14, 2024
Last update
Jul 18, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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