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Trial registered on ANZCTR


Registration number
ACTRN12616001326482
Ethics application status
Approved
Date submitted
20/09/2016
Date registered
22/09/2016
Date last updated
15/02/2019
Date data sharing statement initially provided
15/02/2019
Date results information initially provided
15/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vitamin B12 Blood Level Absorption Study in Healthy Adult Volunteers.
Scientific title
Vitamin B12 Blood Level Absorption Study in Healthy Adult Volunteers.
Secondary ID [1] 290179 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin B12 Deficiency 300320 0
Condition category
Condition code
Diet and Nutrition 300186 300186 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To Evaluate the Absorption Efficacy Characteristics and Further Safety Over a 6-hour period of Vitamin B12 [1000 mcg administered as ONE dose orally] from SIX preparations to Healthy Participants. ORAL delivery, ONE preparation per participant/day, for six days. Each of the six preparations will be administered to each participant in the same order across six consecutive days. Clinical Trial coordinator to oversee dose administered.
1) FitBioceuticals 2 sprays= 1000 mcg
2) Blackmores 10 tablets= 1000 mcg
3) Vitamin Shoppe 1mL= 1000 mcg
4) Bioceuticals enzymatic dissolvable 1 tablet= 1000 mcg
5) Jarrow 1 capsule= 1000 mcg
6) InMed Technologies LLC 0.3mL = 1000 mcg
Intervention code [1] 295939 0
Treatment: Other
Comparator / control treatment
Allocation: Non-Randomised; Self Control; Active Control; Endpoint Classification: Efficacy of Absorption / Safety Trial; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Absorption Characteristics of Vitamin B12 Preparations; Overall Study Duration: 12 Weeks to Complete recruitment and study. Sequential allocation to each preparation once the target sample size has been met. Comparing six preparations of Vitamin B12, with each participant acting as their own control.
Control group
Active

Outcomes
Primary outcome [1] 299673 0
Absorption Characteristics: Plasma concentration of Vitamin B12
Timepoint [1] 299673 0
Blood draws at t-0 (baseline), 60, 180, 360 minutes. 4 time points/day over six consecutive days.
Secondary outcome [1] 327790 0
Safety. Clinical Trial Coordinator to monitor participants and any adverse effects. Any adverse effects will be documented in the individuals Case Report Form. Side effects may include (but not limited to); itchy skin, headache and nausea.
Timepoint [1] 327790 0
Trial Coordinator will monitor each participant and adverse effects from baseline to 6 hours post dose.

Eligibility
Key inclusion criteria
1) Participants > 18 years of age at time of entry on study
2) No evidence or documented history of chronic disease
3) Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment
4) Caucasian Ethnicity
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any clinically relevant abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including:
1) Previous history of abnormal blood results i.e. FBE, U and E Liver Function Tests and vital signs
2) Use of vitamin or mineral supplements 1 week before the study and/or known adverse side effects to supplements
3) Use of pharmaceutical drugs (prescribed or over-the-counter)
4) Female participants who are lactating or pregnant
5) The current use of any nicotine products including:
i) nicotine patches/gum ii) tobacco smoking
6) History or alcohol or substance abuse including the use of any illicit drugs
7) Presence of chronic/acute illnesses including hypertension, high cholesterol, diabetes, obesity, irritable bowel syndrome, inflammatory bowel disease, coeliac disease
8) Any psychiatric disorders by history or examination that would prevent completion of the study or result in possible adverse events for the participant [suicide thoughts or euthanasia requests]
9) Vegetarianism

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294545 0
Commercial sector/Industry
Name [1] 294545 0
Medlab Clinical
Address [1] 294545 0
66 McCauley Street, Alexandria, NSW, 2015
Country [1] 294545 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medlab Clinical
Address
66 McCauley Street, Alexandria, NSW, 2015
Country
Australia
Secondary sponsor category [1] 293416 0
None
Name [1] 293416 0
Address [1] 293416 0
Country [1] 293416 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295981 0
National Institue of Integrative Medicine
Ethics committee address [1] 295981 0
11-23 Burwood Rd, Hawthorn, Melbourne, VIC, 3122
Ethics committee country [1] 295981 0
Australia
Date submitted for ethics approval [1] 295981 0
20/05/2014
Approval date [1] 295981 0
22/05/2014
Ethics approval number [1] 295981 0
0013E

Summary
Brief summary
There is significant interest from researchers, general practitioners and the public re: the administration of Vitamin B12 supplements for health maintenance or disease treatments. The aim of this study is to evaluate the absorption characteristics of a selected group of Australian and U.S MARKETED OVER THE COUNTER (OTC) VITAMIN B12 PRODUCTS. As such this study purposes to evaluate the absorption characteristics of these products.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69130 0
Prof Luis Vitetta
Address 69130 0
Medlab Clinical. 66 McCauley Street, Alexandria, NSW, 2015
Country 69130 0
Australia
Phone 69130 0
+61281880311
Fax 69130 0
Email 69130 0
luis_vitetta@medlab.co
Contact person for public queries
Name 69131 0
Miss Tessa Nikov
Address 69131 0
Medlab Clinical. 66 McCauley Street, Alexandria, NSW, 2015
Country 69131 0
Australia
Phone 69131 0
+61281880311
Fax 69131 0
Email 69131 0
tessa_nikov@medlab.co
Contact person for scientific queries
Name 69132 0
Prof Luis Vitetta
Address 69132 0
Medlab Clinical. 66 McCauley Street, Alexandria, NSW, 2015
Country 69132 0
Australia
Phone 69132 0
+61281880311
Fax 69132 0
Email 69132 0
luis_vitetta@medlab.co

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 1349 0
http://www.mdpi.com/2079-4983/9/1/12:
J. Funct. Biomater. 2018, 9(1), 12; https://doi.org/10.3390/jfb9010012
Published: 21 January 2018

Route and Type of Formulation Administered Influences the Absorption and Disposition of Vitamin B12 Levels in Serum
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary