Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001027404
Ethics application status
Approved
Date submitted
28/07/2016
Date registered
3/08/2016
Date last updated
3/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vitamin D3 Absorption Studies in Healthy Adult Volunteers.
Scientific title
Vitamin D3 Absorption Studies in Healthy Adult Volunteers.
Secondary ID [1] 289768 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin D3 deficiency 299642 0
Condition category
Condition code
Diet and Nutrition 299592 299592 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 in High Dose Vitamin D3 [5000 I.U administered as ONE dose] 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. 5000 I.U. at baseline of one of the following D3 preparations:
1) Metagenics 1000 IU/drop
2) Vitamin Shoppe 1 softgel=5000 IU
3) Solgar 1 veg cap=5000 IU
4) Nature's Way 1 softgel=5000 IU
5) Jarrow 1 softgel=5000 IU
6) InMed Technologies LLC 2 sprays=5000 IU
Intervention code [1] 295422 0
Treatment: Other
Comparator / control treatment
Allocation; Non-Randomised; Self Control; Active Control; Primary Purpose: Absorption Characteristics of Vitamin D3 Preparations; Overall Study. Self control; participants will self administer dose and all SIX preparations are active. Sequential allocation to each preparation once the target sample size has been met.
Control group
Active

Outcomes
Primary outcome [1] 299072 0
Absorption Characteristics ; plasma concentration of Vitamin D3
Timepoint [1] 299072 0
Blood draws at t- 0 (baseline), 60, 180, 360 minutes. 4 time points/day over six consecutive days.
Secondary outcome [1] 326062 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): headache, loss of appetite, dry mouth, nausea and vomitting.
Timepoint [1] 326062 0
Blood draws at t- 0 (baseline), 60, 180, 360 minutes. 4 time points/day over six consecutive days.

Eligibility
Key inclusion criteria
Participants >18 years of age - 80 years of age at time of entry into the study;
1) No evidence or documented history of a chronic disease
2) Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment
Minimum age
18 Years
Maximum age
80 Years
Sex
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
2) Vital signs
3) The use of any nicotine products including;
i) nicotine patches/gum ii) tobacco smoking
4) Alcohol abuse
5) The use of any illicit drugs
6) Unstable angina not well managed with medication
7) Pregnancy or nursing of an infant
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]

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/07/2016
Date of last participant enrolment
Anticipated
Actual
12/12/2016
Date of last data collection
Anticipated
Actual
13/12/2016
Sample size
Target
60
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294161 0
Commercial sector/Industry
Name [1] 294161 0
Medlab Clinical
Country [1] 294161 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medlab Clinical
Address
66 McCauley Street, Alexandria, New South Wales, 2015
Country
Australia
Secondary sponsor category [1] 292994 0
None
Name [1] 292994 0
Address [1] 292994 0
Country [1] 292994 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295569 0
National Institute of Integrative Medicine
Ethics committee address [1] 295569 0
11-23 Burwood Rd, Hawthorn, Melbourne VIC 3122
Ethics committee country [1] 295569 0
Australia
Date submitted for ethics approval [1] 295569 0
01/10/2013
Approval date [1] 295569 0
09/10/2013
Ethics approval number [1] 295569 0
001/072013

Summary
Brief summary
There is significant interest from researchers, general practitioners and the public re: the administration of Vitamin D3 supplements for health maintenance or disease treatments. The aim of this study is to evaluate the absorption characteristics of a selected group of U.S. MARKETED OVER THE COUNTER (OTC) PRO-HORMONE (D3) PRODUCTS. These products are not commercially available in Australia. As such this study proposes to evaluate the absorption characteristics of these products.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67754 0
Prof Luis Vitetta
Address 67754 0
Medlab Clinical, 66 McCauley Street, Alexandria, New South Wales 2015
Country 67754 0
Australia
Phone 67754 0
+61 (2) 8188 0311
Fax 67754 0
Email 67754 0
[email protected]
Contact person for public queries
Name 67755 0
Miss Tessa Nikov
Address 67755 0
Medlab Clinical, 66 McCauley Street, Alexandria, New South Wales 2015
Country 67755 0
Australia
Phone 67755 0
+61 (2) 8188 0311
Fax 67755 0
Email 67755 0
[email protected]
Contact person for scientific queries
Name 67756 0
Prof Luis Vitetta
Address 67756 0
Medlab Clinical, 66 McCauley Street, Alexandria, New South Wales, 2015
Country 67756 0
Australia
Phone 67756 0
+61 (2) 8188 0311
Fax 67756 0
Email 67756 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.