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
  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: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Keywords provided by University of Aarhus:
absorption test
cobalamin
holotranscobalamin
vitamin B12

Additional relevant MeSH terms:
Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Vitamins
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014