NCT00306358

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2006

Completed
Last Updated

March 23, 2006

Status Verified

March 1, 2006

First QC Date

March 22, 2006

Last Update Submit

March 22, 2006

Conditions

Vitamin B12 Absorption

Keywords

absorption testcobalaminholotranscobalaminvitamin B12

Outcome Measures

Primary Outcomes (1)

  • Changes in plasma holotranscobalamin after intake of vitamin B12

Secondary Outcomes (1)

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

Interventions

Vitamin B12 (Cyanocobalamin)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Above 18 years North european origin Read and understand Danish

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus Sygehus

Aarhus, 8000, Denmark

Location

MeSH Terms

Interventions

Vitamin B 12

Intervention Hierarchy (Ancestors)

CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Anne-Mette Hvas, Cand Med PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 22, 2006

First Posted

March 23, 2006

Study Start

May 1, 2005

Study Completion

October 1, 2005

Last Updated

March 23, 2006

Record last verified: 2006-03

Locations

DK(1)