NanoCelle® B12

Delivery Platform
ANZCTR: ACTRN12616001326482
Date Started: 2014-05-20
Progress - Discovery - Completed

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Study Site:

Northern Cancer Institute, 38 Pacific Hwy, St Leonards, NSW, 2065

Formulation:

NanoCelle® B12 is a sub-micron spray applied to the oro-buccal membrane delivering 1000 mcg in 2 actuation of the pump. The absorption characteristics of Medlab NanoCelle® B12 were compared to 6 other Vitamin B12 formulations in a Phase 0, absorption study.

About Trial:

This study assesses the vitamin B12 blood level absorption in healthy adult volunteers.

Vitamin B12 is required for proper red blood cell formation, neurological function, and DNA synthesis. Vitamin B12 deficiency is characterised by megaloblastic anemia, fatigue, weakness, constipation, loss of appetite, and weight loss. The main causes of vitamin B12 deficiency include vitamin B12 malabsorption from food, pernicious anemia, postsurgical malabsorption, and dietary deficiency.

Source: National Institutes of Health, Office of Dietary Supplements, Vitamin B12. March 2020

There is significant interest from researchers, general practitioners and the public regarding 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.

HREC Date:

2014-05-22

HREC Date:

2014-05-22

HREC ID:

0013E

PUBLICATIONS OR CONFERENCES ASSOCIATED WITH THE PROGRAM

Scientific Application for Innovative Delivery Systems: Bacteria and Nanotechnology Platforms

The 5th Annual Symposium of Drug Delivery Systems Oct 20-22, 2015. Beijing, China.

Date:          2015-10-20

Authors:   Coulson S

Invitation to Chair session on Nanotechnologies for Drug Delivery Systems: Redefining the Curve - Sustainable Compound Delivery Through Nanoparticles.

BIT’s 14th Annual Congress of IDDST June 16-18, 2016. South Korea

Date:          2016-06-16

Authors:   Hall S

Nutraceuticals and Chemotherapy Induced Peripheral Neuropathy (CIPN): A Systematic Review.

Clinical Nutrition 2013; 32(6): 888-893

Date:          2013-04-15

Authors:   Schloss JM,Colosimo M, Airey C, Vitetta L

Chemotherapy-induced peripheral neuropathy (CIPN) and vitamin B12 deficiency

Support Care Cancer 2015;23(7):1843-50

Date:          2015-07-01

Authors:   Schloss J, Colosimo M, Airey C, Vitetta L

New Insights into potential prevention and management options for chemotherapy-induced peripheral neuropathy

Asia-Pacific Journal of Oncology Nursing 2015; 3(1):73-85.

Date:          2016-01-01

Authors:   Schloss J, Colosimo M, Vitetta L

A randomised, placebo-controlled trial assessing the efficacy of an oral B group vitamin in preventing the development of chemotherapy-induced peripheral neuropathy (CIPN)

Support Care Cancer 2016;25(1):195-204.

Date:          2017-01-02

Authors:   Schloss JM, Colosimo M, Airey C, Masci P, Linnane AW, Vitetta L

Route and Type of Formulation Administered Influences the Absorption and Disposition of Vitamin B12 Levels in Serum

Journal of Functional Biomaterials. 2018, 9(1), 12; https://doi.org/10.3390/jfb9010012

Date:          2017-12-23

Authors:   Vitetta L, Zhou J, Manuel R, Dal Forno S, Hall S, Rutolo D