# US 11,077,085 B2 · Dietary macro/micronutritional supplement for patients undergoing kidney dialysis

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- Number: US 11,077,085 B2
- Document ID: US11077085B2
- Status: Granted
- Kind: B2
- Application number: 16/326,250
- Filed: 2017-08-23
- Published: 2019-07-11
- Granted: 2021-08-03
- Earliest claimed: 2016-08-26
- Assignees: Atif Dabdoub
- Applicants: Atif Dabdoub
- Inventors: Atif Dabdoub
- Web page: https://patentgrep.com/patent/US11077085B2

## CPC

- A61K 31/205: Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
- A23L 2/52: Adding ingredients (adding preservatives A23B70/10)
- A23L 33/105: Plant extracts, their artificial duplicates or their derivatives
- A23L 33/125: containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates (indigestible substances A23L33/21)
- A23L 33/15: Vitamins
- A23L 33/155: Vitamins A or D
- A23L 33/16: Inorganic salts, minerals or trace elements
- A23L 33/175: Amino acids
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/14: Particulate form, e.g. powders, {Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles (microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51)}
- A61K 31/122: having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
- A61K 31/191: having two or more hydroxy groups, e.g. gluconic acid
- A61K 31/194: having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
- A61K 31/197: the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid (carnitine A61K31/205)
- A61K 31/201: having one or two double bonds, e.g. oleic, linoleic acids
- A61K 31/202: having three or more double bonds, e.g. linolenic (eicosanoids, e.g. leukotrienes A61K31/557)
- A61K 31/232: having three or more double bonds, e.g. etretinate
- A61K 31/295: Iron group metal compounds
- A61K 31/375: Ascorbic acid, i.e. vitamin C; Salts thereof
- A61K 31/4188: condensed with other heterocyclic ring systems, e.g. biotin, sorbinil
- A61K 31/4415: Pyridoxine, i.e. Vitamin B6 (pyridoxal phosphate A61K31/675)
- A61K 31/455: Nicotinic acids, e.g. niacin; Derivatives thereof, e.g. esters, amides
- A61K 31/51: Thiamines, e.g. vitamin B1
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 31/525: Isoalloxazines, e.g. riboflavins, vitamin B2
- A61K 31/593: 9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
- A61K 31/714: Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
- A61K 33/04: Sulfur, selenium or tellurium; Compounds thereof
- A61K 33/06: Aluminium, calcium or magnesium; Compounds thereof {, e.g. clay}
- A61K 33/26: Iron; Compounds thereof
- A61K 33/30: Zinc; Compounds thereof
- A61K 36/45: Ericaceae or Vacciniaceae (Heath or Blueberry family), e.g. blueberry, cranberry or bilberry
- A61K 36/736: Prunus, e.g. plum, cherry, peach, apricot or almond
- A61K 36/752: Citrus, e.g. lime, orange or lemon
- A61K 36/9066: Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
- A61K 47/02: Inorganic compounds
- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61P 3/02: Nutrients, e.g. vitamins, minerals
- A61P 13/12: of the kidneys
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION

## Abstract

Provided herein is a nutritional supplement designed to support kidney and cardiac function as well as mitochondrial energy function needs in patients undergoing hemodialysis. This supplement replenishes essential vitamins and minerals that are lost during dialysis, does not contain compounds that may specifically cause harm to dialysis patients, and provides support for tissues undergoing oxidative stress.

## Claims

### Claim 1

A kit for a subject (i) with kidney disease or at risk of kidney disease or (ii) undergoing kidney dialysis comprising the following components:
(a) a unit dose composition consisting of;
vitamin B1 in the amount of 0.1 mg to 50 mg per unit dose;
vitamin B2 in the amount of 0.1 mg to 2 mg per unit dose;
vitamin B3 in the amount of 1 mg to 40 mg per unit dose;
vitamin B5 in the amount of 1 mg to 20 mg per unit dose;
vitamin B6 in the amount of 1 mg to 100 mg per unit dose;
vitamin B7 in the amount of 10 μg to 500 μg per unit dose;
vitamin B9 in the amount of 0.05 mg to 1.0 mg per unit dose;
vitamin B12 in the amount of 1 μg to 150 μg per unit dose;
vitamin C in the amount of 10 mg to 2,000 mg per unit dose;
a pharmaceutically-acceptable compound of calcium in the amount of 100 mg to 2,500 mg per unit dose;
vitamin D3 in the amount of 1 μg to 100 μg per unit dose;
a pharmaceutically-acceptable compound of magnesium in the amount of 100 mg to 500 mg per unit dose;
a pharmaceutically-acceptable compound of zinc in the amount of 1 mg to 40 mg per unit dose;
a pharmaceutically-acceptable compound of selenium in the amount of 10 μg to 400 μg per unit dose;
a pharmaceutically-acceptable compound of iron in the amount of 1 mg to 45 mg per unit dose;
L-carnitine-L-tartrate or acetyl-L-carnitine;
maltodextrin; and
optionally a citrus bioflavonoid, powdered extract of cranberry or cherry, or any combination thereof;
(b) a capsule comprising marine omega 3 fatty acids in the amount of 500 mg to 4,000 mg per unit dose; and
(c) a gel comprising coenzyme Q10 in the amount of 70 mg to 400 mg per unit dose.

### Claim 2 (depends on 1)

The kit of claim 1, wherein the marine omega 3 fatty acids comprise docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) in the weight ratio (EPA:DHA) of 1:1 to 4:1.

### Claim 3 (depends on 1)

The kit of claim 1, wherein coenzyme Q10 is ubiquinol.

### Claim 4 (depends on 1)

The kit of claim 1, wherein the kit further comprises a capsule comprising turmeric, wherein the turmeric is in the amount of 1 g to 3 g per unit dose.

### Claim 5 (depends on 1)

The kit of claim 1, wherein the calcium is calcium citrate, the magnesium is magnesium citrate, the zinc is zinc citrate; the selenium is sodium selenate; and the iron is iron gluconate.

### Claim 6 (depends on 1)

The kit of claim 1, a citrus bioflavonoid, a powdered extract of cranberry and/or cherry, or a combination thereof is present in component (a).

### Claim 7 (depends on 1)

The kit of claim 1, wherein component (a) consists of
vitamin B1 in the amount of 0.5 mg to 2 mg per unit dose;
vitamin B2 in the amount of 0.5 mg to 2 mg per unit dose;
vitamin B3 in the amount of 1 mg to 20 mg per unit dose;
vitamin B5 in the amount of 1 mg to 15 mg per unit dose;
vitamin B6 in the amount of 1 mg to 10 mg per unit dose;
vitamin B7 in the amount of 10 μg to 100 μg per unit dose;
vitamin B9 in the amount of 0.1 mg to 1.0 mg per unit dose;
vitamin B12 in the amount of 1 μg to 10 μg per unit dose;
vitamin C in the amount of 100 mg to 300 mg per unit dose;
a pharmaceutically-acceptable compound of calcium in the amount of 100 mg to 1,000 mg per unit dose;
vitamin D3 in the amount of 1 μg to 100 μg per unit dose;
a pharmaceutically-acceptable compound of magnesium in the amount of 100 mg to 500 mg per unit dose;
a pharmaceutically-acceptable compound of zinc in the amount of 5 mg to 20 mg per unit dose;
a pharmaceutically-acceptable compound of selenium in the amount of 10 μg to 100 μg per unit dose;
a pharmaceutically-acceptable compound of iron in the amount of 5 mg to 30 mg per unit dose;
L-carnitine-L-tartrate or acetyl-L-carnitine;
maltodextrin; and
optionally a citrus bioflavonoid, powdered extract of cranberry or cherry, or any combination thereof.

### Claim 8 (depends on 1)

The kit of claim 1, wherein the citrus bioflavonoid and powdered extract of cranberry or cherry are present in the composition.

### Claim 9 (depends on 1)

A method for replenishing vitamins and minerals in a subject (i) having kidney disease or at risk of kidney disease or (ii) undergoing kidney dialysis comprising administering to the subject the components in the kit of claim 1.

### Claim 10 (depends on 9)

The method of claim 9, wherein the method increases the energy level of the subject.