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

University of Aarhus

Status: Completed

Conditions: Vitamin B12 Absorption

Treatments: Drug: Vitamin B12 (Cyanocobalamin)

Study type: Interventional

Funder types: Other

Identifiers

NCT00306358

20050067

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)