TRIM: Danish Form and Dose Study on Vitamin B12

NCT ID: NCT02832726

Last Updated: 2016-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-06-30

Brief Summary

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The study investigates the absorption of different doses of hydroxocobalamin and cyanocobalamin in a vitamin B12-replete Danish population.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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cyano-hydroxo B12

Absorption of 3 doses of 9 ug cyano-B12 and 9 ug hydroxo-B12 for two days (the CobaSorb test). No drugs given.

Group Type ACTIVE_COMPARATOR

Vitamin B12

Intervention Type DIETARY_SUPPLEMENT

Cyano-B12 doses

Absorption of 3 doses of 3 ug, 6 ug, and 9 ug cyano-B12 for two days (the CobaSorb test). No drugs given.

Group Type ACTIVE_COMPARATOR

Vitamin B12

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Vitamin B12

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Cobalamin

Eligibility Criteria

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Inclusion Criteria

* At least 18 years old

Exclusion Criteria

* Use of vitamin pills with vitamin B12 within the last two weeks of the study
* Treatment with vitamin B12 injections within the last year
* Known chronic systemic disease
* Not able to give informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Greibe E, Mahalle N, Bhide V, Heegaard CW, Naik S, Nexo E. Increase in circulating holotranscobalamin after oral administration of cyanocobalamin or hydroxocobalamin in healthy adults with low and normal cobalamin status. Eur J Nutr. 2018 Dec;57(8):2847-2855. doi: 10.1007/s00394-017-1553-5. Epub 2017 Oct 16.

Reference Type DERIVED
PMID: 29038891 (View on PubMed)

Other Identifiers

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KBA B48 2013

Identifier Type: -

Identifier Source: org_study_id

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