Methods and kits for co-administration of nutritional supplements
Inventors
Giordano, John A. • Balzer, Charles J.
Assignees
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Publication Number
US-8617617-B2
Publication Date
2013-12-31
Expiration Date
Abstract
The present invention relates to methods of co-administration of various vitamin and mineral compositions, and in a specific embodiment, said methods comprise co-administering one composition comprising vitamin A, vitamin D, vitamin C, vitamin E, folic acid, vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, calcium, iron, magnesium, zinc, and/or copper, and a second composition comprising omega-3 fatty acids such as DHA, to supplement the nutritional needs of individuals within physiologically stressful states; and kits provided for co-administration of various vitamin and mineral compositions, and in a specific embodiment, said kits comprise one composition comprising vitamin A, vitamin D, vitamin C, vitamin E, folic acid, vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, calcium, iron, magnesium, zinc, and/or copper, and a second composition comprising omega-3 fatty acids such as DHA, to supplement the nutritional needs of individuals within physiologically stressful states.
Core Innovation
The invention relates to methods and kits for co-administering two oral nutritional compositions to subjects in physiologically stressful states, including pregnancy and lactation. A first composition contains a multi-vitamin/multi-mineral blend comprising vitamins A, D, C, E, folic acid, vitamin B1, vitamin B2, vitamin B6, vitamin B12, and niacin, together with minerals calcium, iron, magnesium, zinc, and copper, with one or more pharmaceutically acceptable carriers.
A second composition contains omega-3 fatty acids, including DHA, together with one or more pharmaceutically acceptable carriers. The kit format provides the two separate compositions as part of a co-administration arrangement, where each composition is configured for oral administration. The subject receives both compositions in the physiologically stressful state.
The document further describes optional and excludable ingredient limitations for the compositions, including configurations that are substantially free of certain other added vitamins, added minerals, or added inactive or excipient compounds. Documented example formulations include caplet or capsule and gel-cap for omega-3, as well as liquid or oil form, and an example double-blind placebo-controlled study in pregnant and lactating women is described.
Claims Coverage
Independent claim 1 is directed to a two-part oral nutritional kit comprising a specified vitamin/mineral composition and a specified omega-3 fatty acid composition, each with pharmaceutically acceptable carriers. The main inventive features are refined in dependent claims by constraining ingredient identity, constraining excluded added nutrients, constraining ingredient amounts, and narrowing presentation form.
Two-part nutritional kit with specified vitamin/mineral blend and omega-3 blend
A kit comprising a first composition consisting of vitamin A, vitamin D, vitamin C, vitamin E, folic acid, vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, calcium, iron, magnesium, zinc, copper and one or more pharmaceutically acceptable carriers and a second composition consisting of omega-3 fatty acids and one or more pharmaceutically acceptable carriers.
First composition free of added vitamins and minerals
The kit is defined such that the first composition is free of any other added minerals and free of any other added vitamins.
Omega-3 fatty acids including a specified DHA amount
The kit includes a second composition containing 250 mg DHA.
Folic acid as natural folate derivatives including polyglutamyl forms
The folic acid component includes one or more natural folate derivatives chosen from a defined list of tetrahydrofolic-acid derivatives, including polyglutamyl derivatives, such as (6S)-tetrahydrofolic acid and substituted forms with polyglutamyl derivatives.
Omega-3 fatty acids enclosed within a gel-cap
The omega-3 fatty acids are enclosed within a gel-cap.
Across the independent kit concept, the claims focus on pairing a defined multi-vitamin/multi-mineral composition with a separate omega-3 fatty acid composition in a single kit, while using exclusions for other added vitamins and minerals, specifying DHA and folate derivative identity, and constraining omega-3 presentation in a gel-cap.
Stated Advantages
Improvements in vitamin/mineral and DHA status in pregnant and lactating women.
Improvements in related homocysteine outcomes.
Improvement in length of gestation outcomes.
Documented Applications
Use in a double-blind placebo-controlled study in pregnant and lactating women, reporting improvements in vitamin/mineral and DHA status and related homocysteine and gestation outcomes.
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