Plasma Holotranscobalamin as Compared to Plasma Cobalamins for Assessment of Vitamin B12 Absorption
Information source: University of Aarhus
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vitamin B12 Absorption
Intervention: Vitamin B12 (Cyanocobalamin) (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Aarhus Official(s) and/or principal investigator(s):
Anne-Mette Hvas, Cand Med PhD, Principal Investigator, Affiliation: Dept. of Clinical Biochemistry, Skejby Sygehus, 8000 Aarhus, Denmark
Summary
In the present study the design of the vitamin B12 absorption test, CobaSorb, is further
optimised. We investigate which test – measurement of holotranscobalamin or cobalamins –
could be used for reflection of vitamin B12 absorption. Furthermore, we prolong the duration
of vitamin B12 administration in order to determine the final duration of the vitamin B12
absorption test CobaSorb.
Seventy-eight healthy individuals (age 21-81 years) are treated with three oral doses of 9
microgram cyanocobalamin per day for five successive days. Non-fasting blood samples are
collected on day 1-5 before administration of the first dose of vitamin B12 and on day 8.
Cobalamins and holotranscobalamin are measured on day 1–5 and 8. The performance of the
vitamin B12 absorption test will be evaluated in individuals with borderline or low levels of
holotranscobalamin or cobalamins (below the 75% percentiles) using a change larger than
2CV(day to day) of holotranscobalamin (22%) and cobalamins (12%) to indicate a change caused
by absorption of the administered vitamin B12.
Clinical Details
Official title: Plasma Holotranscobalamin as Compared to Plasma Cobalamins for Assessment of Vitamin B12 Absorption. Optimisation of a Non-Radioactive Vitamin B12 Absorption Test (CobaSorb)
Study design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Changes in plasma holotranscobalamin after intake of vitamin B12
Secondary outcome: Changes in plasma cobalamins, plasma methylmalonic acid and plasma homocysteine after intake of vitamin B12.
Detailed description:
In the present study the design of the vitamin B12 absorption test, CobaSorb, is further
optimised. We investigate which test â measurement of holotranscobalamin or cobalamins â
could be used for reflection of vitamin B12 absorption. Furthermore, we prolong the duration
of vitamin B12 administration in order to determine the final duration of the vitamin B12
absorption test CobaSorb.
Seventy-eight healthy individuals (age 21-81 years) are treated with three oral doses of 9
microgram cyanocobalamin per day for five successive days. Non-fasting blood samples are
collected on day 1-5 before administration of the first dose of vitamin B12 and on day 8.
Cobalamins and holotranscobalamin are measured on day 1â5 and 8. The performance of the
vitamin B12 absorption test will be evaluated in individuals with borderline or low levels of
holotranscobalamin or cobalamins (below the 75% percentiles) using a change larger than
2CV(day to day) of holotranscobalamin (22%) and cobalamins (12%) to indicate a change caused
by absorption of the administered vitamin B12.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Above 18 years North european origin Read and understand Danish
Exclusion Criteria:
Vitamin B12 treatment within the past 5 years Use of vitamin pills containing >1 microgram
vitamin B12 with in the past 3 weeks Infectious disease Pregnancy Lactation Giving birth
within the past 9 months Use of hormones Known systemic disease
Locations and Contacts
Aarhus Sygehus, Aarhus 8000, Denmark
Additional Information
Starting date: May 2005
Ending date: October 2005
Last updated: March 22, 2006
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