N/A
N=21
Evaluation of Holotranscobalamin as an Indicator of Vitamin B12 Absorption
Disorder of Vitamin B12
Bottom Line
View on ClinicalTrials.gov: NCT00235573 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: Change in Holo-transcobalamin — 124 pmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vitamin B12 (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Nov 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Holo-transcobalamin |
124 | — |
| SECONDARY Total Transcobalamin Measured at Intervals From Baseline to 48 Hours. |
— | — |
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.
Eligibility Criteria
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 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 requirements
Data sourced from ClinicalTrials.gov (NCT00235573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.