Viewing Study NCT00306358



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Study NCT ID: NCT00306358
Status: COMPLETED
Last Update Posted: 2006-03-23
First Post: 2006-03-22

Brief Title: Plasma Holotranscobalamin as Compared to Plasma Cobalamins for Assessment of Vitamin B12 Absorption
Sponsor: University of Aarhus
Organization: University of Aarhus

Study Overview

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
Status: COMPLETED
Status Verified Date: 2006-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 2CVday to day of holotranscobalamin 22 and cobalamins 12 to indicate a change caused by absorption of the administered vitamin B12
Detailed 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 2CVday to day of holotranscobalamin 22 and cobalamins 12 to indicate a change caused by absorption of the administered vitamin B12

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None