Assessing the Efficacy of Different Carrier Systems in Oral Vitamin B12 Supplementation in Healthy Adults With B12 Deficiency

Vitamin B 12 Deficiency Clinical Trial

Official title:

Assessing the Efficacy of Different Carrier Systems in Oral Vitamin B12 Supplementation in Healthy Adults With B12 Deficiency

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06376591
• Other study ID #: LUMHS/B12/Temp/12.04.2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 22, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: Liaquat University of Medical & Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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
• Weight 60 and 100 kg, 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

Related Conditions & MeSH terms

• Vitamin B 12 Deficiency

Intervention

Dietary Supplement:
• Oral Vitamin B12 supplement
Oral Vitamin B12

Other:
• Control group
No B12 intervention

Locations

Country	Name	City	State
Pakistan	Liaquat University of Medical and Health Sciences	Jamshoro

Sponsors (1)

Lead Sponsor	Collaborator
Liaquat University of Medical & Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Supplementation effect on circulatory vitamin B12 levels	Changes in participants serum vitamin B12 levels	one-week
Secondary	Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Any changes in participant's liver function tests (serum levels of Alanine Aminotransferase, Aspartate Aminotransferase, and Alkaline Phosphatase enzymes)	one-week
Secondary	Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Any changes in participant's Kidney function tests (serum levels of creatinine, urea and blood urea nitrogen)	one-week
Secondary	Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Any changes in participant's full blood count	one-week