Assessing the Efficacy of Different Carrier Systems in Oral Vitamin B12 Supplementation
1 other identifier
interventional
70
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2024
CompletedStudy Start
First participant enrolled
April 12, 2024
CompletedFirst Posted
Study publicly available on registry
April 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 14, 2024
CompletedJuly 18, 2024
April 1, 2024
3 months
April 12, 2024
July 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Supplementation effect on circulatory vitamin B12 levels
Changes in serum vitamin B12 levels
Day 1, Day 3, Day 5, Day 7
Secondary Outcomes (1)
Incidence of Treatment-Emergent Adverse Effects
one-week
Study Arms (7)
Sucrosomial® B12 (Center 1)
EXPERIMENTALParticipants will receive an oral single dose of 1000 mcg Sucrosomial® B12 supplement for 7 days.
B-SUB® B12 (Center 1)
ACTIVE COMPARATORParticipants will receive oral single dose of 1000 mcg B-SUB® B12 supplement for 7 days.
Sucrosomial® B12 (Center 2)
EXPERIMENTALParticipants will receive an oral single dose of 1000 mcg Sucrosomial® B12 supplement for 7 days.
Mecogen SL® B12 (Center 2)
ACTIVE COMPARATORParticipants will receive an oral single dose of 1000 mcg Mecogen SL® B12 supplement for 7 days.
Sucrosomial® B12 (Center 3)
EXPERIMENTALParticipants will receive an oral single dose of 1000 mcg Sucrosomial® B12 supplement for 7 days.
Evermin® B12 (Center 3)
ACTIVE COMPARATORParticipants will receive an oral single dose of 1000 mcg Evermin® B12 supplement for 7 days.
Neuromax® B12 (Center 3)
ACTIVE COMPARATORParticipants will receive an oral single dose of 1000 mcg Neuromax® B12 supplement for 7 days.
Interventions
Sucrosomial® B12
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Liaquat University of Medical and Health Sciences
Jamshoro, 76090, Pakistan
Related Publications (1)
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.
PMID: 39582666DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Clinical Biochemistry and Experimental Medicine
Study Record Dates
First Submitted
April 12, 2024
First Posted
April 19, 2024
Study Start
April 12, 2024
Primary Completion
July 7, 2024
Study Completion
July 14, 2024
Last Updated
July 18, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share