Plasma Holotranscobalamin as Compared to Plasma Cobalamins for Assessment of Vitamin B12 Absorption

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00306358
First received: March 22, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted

March 22, 2006
March 22, 2006
May 2005
Not Provided
Changes in plasma holotranscobalamin after intake of vitamin B12
Same as current
No Changes Posted
Changes in plasma cobalamins, plasma methylmalonic acid and plasma homocysteine after intake of vitamin B12.
Same as current
Not Provided
Not Provided
 
Plasma Holotranscobalamin as Compared to Plasma Cobalamins for Assessment of Vitamin B12 Absorption
Plasma Holotranscobalamin as Compared to Plasma Cobalamins for Assessment of Vitamin B12 Absorption. Optimisation of a Non-Radioactive Vitamin B12 Absorption Test (CobaSorb)

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Vitamin B12 Absorption
Drug: Vitamin B12 (Cyanocobalamin)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
October 2005
Not Provided

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

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00306358
20050067
Not Provided
Not Provided
University of Aarhus
Not Provided
Principal Investigator: Anne-Mette Hvas, Cand Med PhD Dept. of Clinical Biochemistry, Skejby Sygehus, 8000 Aarhus, Denmark
University of Aarhus
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP