Compositions, kits and methods for nutrition supplementation
Inventors
Perrin, Philippe • Herry, Guillaume
Assignees
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Abstract
The present invention relates to compositions, kits and methods for the administration of various vitamin, mineral and nutrient compositions, and in a specific embodiment, the compositions, kits and methods may utilize or include vitamin D, iodine, vitamin B1, vitamin B6, vitamin B12, vitamin B2, vitamin B9, vitamin B3, vitamin E, vitamin A, vitamin C, iron, zinc, copper, magnesium, omega 3 fatty acids and one or more pharmaceutically acceptable carriers.
Core Innovation
The described invention relates to prenatal and lactation nutritional supplementation during physiologically stressful states. It proposes a single- or multi-composition vitamin/mineral/omega-3 regimen formulated with one or more pharmaceutically acceptable carriers.
The disclosure centers on compositions that include vitamin D3, iodine, multiple B vitamins, vitamins E, A, and C, minerals including iron, zinc, copper, and magnesium, and omega-3 fatty acids comprising DHA. It provides specific ingredient sets and contemplated dosage form embodiments, including gelcap and liquid gelcap.
The omega-3 component is presented as DHA, including DHA sources such as algae or microalgae, including Crypthecodinium cohnii, and an example that lacks fish oils. The document further describes measured outcomes in studies involving pregnant and/or lactating women, including nutrient status biomarkers, homocysteine, gestation length associated with DHA, serum 25-hydroxyvitamin D, and increased iodide versus control.
Claims Coverage
The partial content identifies one independent claim. That independent claim defines a vitamin/mineral/omega-3 composition with specified amounts and pharmaceutically acceptable carriers, with dependent claims refining the dosage form, DHA source, and exclusion of fish oils; this yields multiple inventive features associated with the single independent claim.
Specified vitamin D, iodine, B vitamins, vitamins A, C, E; iron, zinc, copper, magnesium and DHA amounts with pharmaceutically acceptable carriers
A composition consisting of vitamin D in an amount of about 1000 I.U., iodine in an amount of about 150 μg, vitamin B1 in an amount of about 1.6 mg, vitamin B6 in an amount of about 2.5 mg, vitamin B12 in an amount of about 12 μg, vitamin B2 in an amount of about 1.8 mg, vitamin B9 in an amount of about 1.0 mg, vitamin E in an amount of about 20 I.U., vitamin A in an amount of about 1100 I.U., vitamin C in an amount of about 30 mg, vitamin B3 in an amount of about 15 mg, iron in an amount of about 29 mg, zinc in an amount of about 25 mg, copper in an amount of about 2.0 mg, magnesium in an amount of about 20 mg, omega 3 fatty acids comprising DHA in an amount of about 200 mg, and one or more pharmaceutically acceptable carriers.
Gelcap dosage form
The composition in which the dosage form is provided as a gelcap.
Liquid gelcap dosage form
The composition in which the dosage form is a liquid gelcap composition.
Algae oil DHA source
The composition in which the DHA is sourced from algae oil.
Microalgae Crypthecodinium cohnii DHA source
The composition in which the algae oil is obtained from the microalgae Crypthecodinium cohnii.
Lacking fish oils
The composition in which the claimed composition lacks fish oils.
Overall, the claim coverage in the partial content centers on a defined multi-nutrient vitamin/mineral/omega-3 composition containing specified amounts of DHA and multiple vitamins and minerals, together with carrier(s). Dependent inventive features further narrow the formulation by specifying gelcap or liquid gelcap dosage forms, selecting algae- and microalgae-derived DHA sources (Crypthecodinium cohnii), and limiting the composition by lacking fish oils.
Stated Advantages
Statistically significant nutritional improvements reported in the disclosed double-blind placebo-controlled 6-month trial.
Increase in gestation length by about 6 days associated with DHA in the disclosed study.
Improved iodine and vitamin D status, including increased iodide versus control and a reported serum 25-hydroxyvitamin D level toward about 30 ng/mL in the disclosed 3-month study.
Documented Applications
Prenatal and lactation nutritional supplementation during physiologically stressful states.
Use in pregnant/lactating women in a double-blind placebo-controlled 6-month trial measuring nutrient status biomarkers and homocysteine and reporting gestation length increase associated with DHA.
Use in a 3-month study assessing iodine and vitamin D status (serum 25-hydroxyvitamin D and iodide) versus control.
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