None listed
Conditions
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.
Interventions
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
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
Sponsors
Medlab Clinical
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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
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
Outcome results
None listed