Plasma Holotranscobalamin as Compared to Plasma Cobalamins for Assessment of Vitamin B12 Absorption - Full Text View

Sponsor:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00306358

Purpose

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.

Condition	Intervention
Vitamin B12 Absorption	Drug: Vitamin B12 (Cyanocobalamin)

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
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)

Resource links provided by NLM:

Drug Information available for: Vitamin B 12 Hydroxocobalamin

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

Changes in plasma holotranscobalamin after intake of vitamin B12

Secondary Outcome Measures:

Changes in plasma cobalamins, plasma methylmalonic acid and plasma homocysteine after intake of vitamin B12.

Estimated Enrollment:	78
Study Start Date:	May 2005
Estimated Study Completion Date:	October 2005

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 2CV(day to day) of holotranscobalamin (22%) and cobalamins (12%) to indicate a change caused by absorption of the administered vitamin B12.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00306358

Locations

Denmark
Aarhus Sygehus
Aarhus, Denmark, 8000

Sponsors and Collaborators

University of Aarhus

Investigators

Principal Investigator:

Anne-Mette Hvas, Cand Med PhD

Dept. of Clinical Biochemistry, Skejby Sygehus, 8000 Aarhus, Denmark

More Information

No publications provided

Study ID Numbers:	20050067
Study First Received:	March 22, 2006
Last Updated:	March 22, 2006
ClinicalTrials.gov Identifier:	NCT00306358 History of Changes
Health Authority:	Denmark: Ethics Committee

Keywords provided by University of Aarhus:

absorption test
cobalamin
holotranscobalamin
vitamin B12

Additional relevant MeSH terms:

Vitamin B Complex
Hematinics
Therapeutic Uses
Growth Substances
Vitamins
Hematologic Agents

Physiological Effects of Drugs
Hydroxocobalamin
Vitamin B 12
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010