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

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: Completed
• Conditions: Vitamin B 12 Deficiency
• Intervention / Treatment: Dietary supplement: Vit B12; Dietary supplement: Vit B12; Dietary supplement: Vit B12; Dietary supplement: Vit B12; Dietary supplement: Vit B12

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: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Supplementation effect on circulatory vitamin B12 levels	Changes in serum vitamin B12 levels	Day 1, Day 3, Day 5, Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Effects	Number of participants report treatment-emergent adverse effects	one-week

Collaborators and Investigators

• Sponsor: Liaquat University of Medical & Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2024
• Primary Completion (Actual): July 7, 2024
• Study Completion (Actual): July 14, 2024

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin B Deficiency; Vitamin B 12 Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Hematinics; Vitamin B 12; Hydroxocobalamin
• Other Study ID 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