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Trial registered on ANZCTR


Registration number
ACTRN12618001177246
Ethics application status
Approved
Date submitted
12/07/2018
Date registered
16/07/2018
Date last updated
13/02/2019
Date data sharing statement initially provided
13/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Medlab NanoCelle™ D3 hormone blood level absorption study in healthy adult volunteers.
Scientific title
Medlab NanoCelle™ D3 hormone blood level absorption study in healthy adult volunteers.
Secondary ID [1] 295543 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin D3 deficiency 308812 0
Condition category
Condition code
Diet and Nutrition 307743 307743 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. To evaluate the absorption characteristics and further safety over a 6-hour period of Medlab Clinical’s NanoCelle™ D3 (Vitamin D3 as Cholecalciferol) [5000 I.U. administered as a single administration oro-buccal spray/10 sprays/1.5 mL] to healthy participants.

2. Blood samples will be collected from participants at 4 time points over a 6 hours period for PK data.

Study staff will administered the above dose to study participants between 8 and 9 am on dosing day (Day 1). A baseline blood sample will be collected from participants prior to the administration of the IP and at 60, 180 and 360 minutes. Unused product will be disposed of at site.
Intervention code [1] 301845 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306727 0
Medlab Vitamin D3 formulation pharmacokinetics (as summarised using Cmax, Auc and Tmax) using blood samples'
Timepoint [1] 306727 0
Blood samples collection at 0, 60, 180 and 360 minutes.
Secondary outcome [1] 349366 0
Product safety
Timepoint [1] 349366 0
Adverse events monitoring and reporting assessed from informed consent signing to 24 hours post-dose and will be recorded in participant Case Report Forms. Adverse events are both self-reported and assessed by direct observation. The Principal Investigator will determine if a relationship between the study product and/or procedure and adverse event is definite, probable, possible, unlikely or unrelated.

Eligibility
Key inclusion criteria
1. Participants greater than or equal to 18 years of age at time of entry on study;
2. No evidence or documented history of a chronic disease;
3. Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment;
Minimum age
18 Years
Maximum age
50 Years
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 or planning to become pregnant;
5. The current use of any nicotine products including:
i) nicotine patches / gum;
ii) tobacco smoking;
6. History of 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, sarcoidosis, hyperparathyroidism, histoplasmosis.
8. Any psychiatric disorders by history or examination that would prevent completion of the study or result in possible adverse events for the participant [i.e. 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
Phase 0
Type of endpoint(s)
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Medlab has changed its priorities and this project has been withdrawn prior to start of patient recruitment.
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
Recruitment postcode(s) [1] 23445 0
2015 - Alexandria

Funding & Sponsors
Funding source category [1] 300120 0
Commercial sector/Industry
Name [1] 300120 0
Medlab Clinical Ltd
Address [1] 300120 0
66 McCauley Street, Alexandria NSW 2015
Country [1] 300120 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medlab Clinical Ltd
Address
66 McCauley Street, Alexandria NSW 2015
Country
Australia
Secondary sponsor category [1] 299521 0
None
Name [1] 299521 0
Address [1] 299521 0
Country [1] 299521 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300960 0
National Institute of Integrative Medicine Human Research Ethics Committee [EC00436]
Ethics committee address [1] 300960 0
11-23 Burwood Rd, Hawthorn, Melbourne VIC 3122
Ethics committee country [1] 300960 0
Australia
Date submitted for ethics approval [1] 300960 0
Approval date [1] 300960 0
02/07/2018
Ethics approval number [1] 300960 0
0045E_2018

Summary
Brief summary
The study investigates the absorption characteristics and safety of Medlab’s NanoCelle D3 (Vitamin D3 as cholecalciferol) administered to 8 healthy individuals. The dose to be administered in 10 sprays/5000 I.U./1.5mL. A total of four 10 mL blood samples will be collected from each participant at 0, 60, 180 and 360 minutes. The total study duration per participant is approximately 7.5 hours.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85422 0
Prof Luis Vitetta
Address 85422 0
Medlab Clinical, 66 McCauley Street, Alexandria NSW 2015
Country 85422 0
Australia
Phone 85422 0
+61 2818 80311
Fax 85422 0
+61 2969 93347
Email 85422 0
luis_vitetta@medlab.co
Contact person for public queries
Name 85423 0
Ms Serena Dal Forno
Address 85423 0
Medlab Clinical, 66 McCauley Street, Alexandria NSW 2015
Country 85423 0
Australia
Phone 85423 0
+61 2818 80311
Fax 85423 0
+61 2969 93347
Email 85423 0
serena_dalforno@medlab.co
Contact person for scientific queries
Name 85424 0
Prof Luis Vitetta
Address 85424 0
Medlab Clinical, 66 McCauley Street, Alexandria NSW 2015
Country 85424 0
Australia
Phone 85424 0
+61 2818 80311
Fax 85424 0
+61 2969 93347
Email 85424 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
Study withdrawn
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable