None listed
Conditions
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.
Interventions
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
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
Sponsors
Medlab Clinical
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
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]
Outcome results
None listed