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 range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-07

View on ClinicalTrials.gov More Vitamin B 12 Deficiency trials