NCT02832726

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable healthy

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 14, 2016

Completed
Last Updated

July 14, 2016

Status Verified

June 1, 2016

Enrollment Period

2.3 years

First QC Date

June 28, 2016

Last Update Submit

July 11, 2016

Conditions

Healthy

Keywords

absorption of Vitamin B12

Outcome Measures

Primary Outcomes (1)

  • Vitamin B12 absorption (increase in holotranscobalamin)

    3 days

Study Arms (2)

cyano-hydroxo B12

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin B12

Cyano-B12 doses

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin B12

Interventions

Vitamin B12DIETARY_SUPPLEMENT
Also known as: Cobalamin
Cyano-B12 dosescyano-hydroxo B12

Eligibility Criteria

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

You may qualify if:

  • At least 18 years old

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29038891DERIVED

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 Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2016

First Posted

July 14, 2016

Study Start

January 1, 2014

Primary Completion

May 1, 2016

Study Completion

June 1, 2016

Last Updated

July 14, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

No plan at this point