Status:
COMPLETED
Evaluation of Holotranscobalamin as an Indicator of Vitamin B12 Absorption
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Disorder of Vitamin B12
Eligibility:
All Genders
18-49 years
Phase:
NA
Brief 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 ...
Detailed Description
Part I Screening: Individuals who meet initial screening criteria will be scheduled to have fasting blood samples drawn in the General Clinical Research Center (GCRC). All participants will sign infor...
Eligibility Criteria
Inclusion
- 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
- 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 requirements
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00235573
Start Date
October 1 2005
End Date
November 1 2005
Last Update
December 22 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
General Clinical Research Center, Shands Hospital, University of Florida
Gainesville, Florida, United States, 32610-0322