Assessing the Efficacy of Different Carrier Systems in Oral Vitamin B12 Supplementation (NCT06376591) | Clinical Trial Compass
CompletedNot Applicable
Assessing the Efficacy of Different Carrier Systems in Oral Vitamin B12 Supplementation
Pakistan70 participantsStarted 2024-04-12
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
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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, antibio…
What they're measuring
1
Supplementation effect on circulatory vitamin B12 levels
Timeframe: Day 1, Day 3, Day 5, Day 7
Trial details
NCT IDNCT06376591
SponsorLiaquat University of Medical & Health Sciences