Iron supplement compositions and methods of use thereof

Abstract

The disclosure is directed to iron supplement compositions comprising elemental metal iron and methods of replenishing a subject's iron, ferritin, and/or hemoglobin levels.

We claim: 
     
         1 . An iron supplement composition comprising:
 Elemental metal iron;   a source of nitrate anion (NO 3   − ); and   an acid.   
     
     
         2 . The composition of  claim 1 , wherein the acid is ascorbic acid. 
     
     
         3 . The composition of  claim 1 , wherein the source of nitrate anion is a nitrate salt. 
     
     
         4 . The composition of  claim 3 , wherein the nitrate salt is potassium nitrate. 
     
     
         5 . The composition of  claim 1 , wherein the source of nitrate anion is a botanical source. 
     
     
         6 . The composition of  claim 5 , wherein the botanical source is an  Amaranthus  extract. 
     
     
         7 . The composition of  claim 1 , wherein the amount of the elemental metal iron is 1-100 mg, the amount of the source of nitrate anion provides 30-4000 mg nitrate anion, and the amount of the acid is 10-5000 mg. 
     
     
         8 . The composition of  claim 1 , wherein the amount of the elemental metal iron is 2.5 mg, the amount of the source of nitrate anion provides 87.5 mg nitrate anion, and the amount of the acid is 25 mg. 
     
     
         9 . The composition of  claim 1 , wherein the source of nitrate anion, the elemental metal iron, and the acid are in solid forms. 
     
     
         10 . The composition of  claim 1 , wherein the dosage form of the composition is a capsule, a cachet, a pill, a tablet, a powder, a granule, a pellet, a bead, a particle, a troche, or a pastille. 
     
     
         11 . The composition of  claim 10 , wherein the source of nitrate anion and the elemental metal iron are packaged together in the dosage form. 
     
     
         12 . The composition of  claim 11 , wherein the dosage form of the composition is a plurality of the capsule, the cachet, the pill, the tablet, the granule, the pellet, the bead, the particle, the troche, or the pastille. 
     
     
         13 . The composition of  claim 10 , wherein the source of nitrate anion, the elemental metal iron, and the acid are packaged together in a capsule, a cachet, a pill, or a tablet. 
     
     
         14 . A method of replenishing a subject's iron, ferritin, and/or hemoglobin level, the method comprising:
 orally administering elemental metal iron to the subject; and   orally administering a source of nitrate anion to the subject.   
     
     
         15 . The method of any one of  claims 14 , wherein the subject is diagnosed with anemia, low blood iron level, low ferritin level, and/or low hemoglobin levels. 
     
     
         16 . The method of  claim 15 , wherein the subject exhibits at least one symptom selected from the group consisting of: extreme fatigue, weakness, pale skin, chest pain, fast heartbeat, shortness of breath, headache, dizziness, lightheadedness, cold extremities, tongue inflammation, tongue soreness, brittle nails, pica , and poor appetite. 
     
     
         17 . The method of  claim 15 , wherein the subject has donated blood. 
     
     
         18 . The method of  claim 15 , wherein the subject's hemoglobin level is reduced from donating blood. 
     
     
         19 . The method of  claim 17 , wherein the subject's hemoglobin level is lower than that before donating blood. 
     
     
         20 . The method of  claim 14 , where the subject exhibits reduced gastrointestinal side effect compared to oral administration of iron salts. 
     
     
         21 . The method of  claim 20 , wherein the gastrointestinal side effect is at least one side effect selected from the group consisting of: diarrhea, stomach pain, heartburn, nausea, vomiting, black stools, and constipation. 
     
     
         22 . The method of  claim 14 , where the subject exhibits no side effects from oral administration of the elemental metal iron and the source of nitrate anion. 
     
     
         23 . The method of  claim 14 , wherein the subject is administered 10 mg elemental metal iron and 87.5 mg nitrate anion, the method further comprising orally administering 100 mg ascorbic acid to the subject. 
     
     
         24 . The method of  claim 14 , wherein the subject is administered 0.004-0.22 mmol elemental metal iron/kg body weight and 0.08-1.2 mmol nitrate anion/kg body weight. 
     
     
         25 . The method of  claim 24 , wherein method further comprises orally administering to the subject 0.009-0.12 mmol ascorbic acid/kg body weight. 
     
     
         26 . The method of  claim 25 , wherein the subject is administered 0.0032 mmol elemental metal iron/kg body weight, 0.1000 mmol nitrate anion/kg body weight, and 0.0101 mmol ascorbic acid/kg body weight. 
     
     
         27 . The method of  claim 14 , wherein the source of nitrate anion is a nitrate salt. 
     
     
         28 . The method of  claim 27 , wherein the source of nitrate anion is potassium nitrate. 
     
     
         29 . The method of  claim 14 , wherein the source of nitrate anion is a botanical source. 
     
     
         30 . The method of  claim 29 , wherein the botanical source is an  Amaranthus  extract.