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Evaluation of Holotranscobalamin as an Indicator of Vitamin B12 Absorption

NCT00235573 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2011-12-22

Study results available
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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.

Conditions

  • Disorder of Vitamin B12

Interventions

DIETARY_SUPPLEMENT

Vitamin B12

After taking a fasting blood sample, all subjects were given a light breakfast plus 9 micrograms of vitamin B12. Two more doses of vitamin B12, 9 micrograms each, were administered 6 hours apart.

Sponsors & Collaborators

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • Lynn B Bailey, PhD · University of Florida

  • Gail PA Kauwell, PhD · University of Florida

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2005-11-30
Completion
2005-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00235573 on ClinicalTrials.gov