CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
Vitamin B12dietary
Likely dose
Vitamin B12 27 micrograms total (9 micrograms at baseline, 9 micrograms at 6 hours, 9 micrograms at 12 hours)AI-extracted
Key inclusion· 7
  • No vitamin B12 supplement use or injections within the past year
  • No tobacco products
  • No chronic prescription medications except oral contraceptives
  • BMI 18.5-29.9
Key exclusion· 8
  • History of pernicious anemia, cancer, diabetes, renal disease, hypertension, heart disease, neurological abnormalities, gastrointestinal disorders, lung disease, hepatic disease, hematologic or metabolic disease
  • Vitamin B12 supplement use or injections within past year
  • Pregnant or breast feeding
  • BMI <18.5 or >29.9

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00235573
NCT00235573N/ACompleted

Evaluation of Holotranscobalamin as an Indicator of Vitamin B12 Absorption

University of Florida·interventional·Posted Oct 10, 2005·Updated Dec 22, 2011

In Brief

A clinical study evaluating Vitamin B12 for Disorder of Vitamin B12. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 10, 2005
Enrollment StartOct 1, 2005
Primary CompletionNov 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 20.7 years ago

Interventions

Vitamin B12dietary

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.