CompletedNot Applicable

Evaluation of Holotranscobalamin as an Indicator of Vitamin B12 Absorption

United States21 participantsStarted 2005-10

Plain-language summary

Vitamin B12 is an essential nutrient that the body needs for cells to divide and function normally. Individuals may develop a deficiency of vitamin B12 by either limiting the amount in the diet or by decreased vitamin B12 intake into the body (absorption). Keeping adequate B12 blood levels is important for health. Vitamin B12 deficiency may increase one's risk for developing anemia and can even lead to neurological problems and paralysis if the deficiency is severe and lasts a long time. It is very important for doctors to have accurate tests to determine if people are absorbing vitamin B12 normally so that treatment can be started before severe clinical problems occur. The purpose of this research is to provide new information that may help scientists develop a better method to test for problems with absorbing vitamin B12. In this study, changes in the amounts of vitamin B12 bound to protein (transcobalamin) in the blood will be measured after doses of vitamin B12 are taken. If the amounts of this vitamin B12-protein complex (called holo-transcobalamin) change in response to taking a vitamin B12 supplement in normal individuals, it may be possible to use this information to develop a new sensitive test to identify individuals who have problems absorbing vitamin B12. This new vitamin B12 absorption test may be a better clinical test for vitamin B12 absorption than those now available for doctors to use.

Who can participate

Age range

18 Years – 49 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: * No vitamin B12-containing supplement use within past year * No vitamin B12 injections within past year * No use of tobacco products * No chronic use of prescription medications except oral contraceptives * No history of chronic disease (e.g., pernicious anemia, cancer, diabetes, renal disease, hypertension, neurological abnormalities, gastrointestinal disorders) * BMI between 18.5-29.9 * General Chemistry Blood Tests (all values within or near normal range; hemoglobin if female ≥ 11.0 g/dL; if male ≥ 12 g/dL) * B12 status (Serum B12 ≥ 444 pmol/L) * Capable of understanding the informed consent form * Agrees to comply with protocol requirements Exclusion Criteria: * History of pernicious anemia, cancer, diabetes, renal disease, hypertension, heart disease, neurological abnormalities, gastrointestinal disorders, lung disease, hepatic disease, hematologic, or other metabolic diseases that, in the opinion of the Co-Principal Investigators, would affect safety or compliance * Vitamin B12 supplement use or injections within past year * Pregnant or breast feeding * Has BMI \<18.5 or \>29.9 * Has donated or lost a significant volume (\>450 mL) of blood or plasma within 30 days of the study * General chemistry lab values outside of ranges * Serum B12 outside of range listed above * Use of tobacco products * Chronic use of prescription medications except oral contraceptives * Does not understand the informed consent form * Does not agree to comply with protocol…

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

Change in Holo-transcobalamin

Timeframe: Holo-transcobalamin measured at 24 hours after baseline

Trial details

NCT IDNCT00235573

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2005-11

Results submitted2011-09-30

View on ClinicalTrials.gov More Disorder of Vitamin B12 trials