Method of treating vitamin D insufficiency and deficiency
The invention relates to methods and compositions for reducing toxicity associated with administration of vitamin D3, its 25-hydroxylated and 1-hydroxylated forms, and analogs thereof.
1. A method of maintaining or elevating serum levels of 25-hydroxyvitamin D, comprising co-administering to a subject 25-hydroxyvitamin D 3 and 25-hydroxyvitamin D 2 , wherein the weight or molar ratio of 25-hydroxyvitamin D 3 to 25-hydroxyvitamin D 2 is at least 1.5:1.
2. The method of claim 1 , wherein said-co-administering comprises administering a therapeutically effective amount of the 25-hydroxyvitamin D 3 and administering the 25-hydroxyvitamin D 2 in an amount effective to reduce vitamin D toxicity.
3. The method according to claim 1 , wherein the weight or molar ratio of 25-hydroxyvitamin D 3 to 25-hydroxyvitamin D 2 is in a range of 100:1 to 2:1.
4. The method according to claim 1 , wherein the ratio of 25-hydroxyvitamin D 3 to 25-hydroxyvitamin D 2 is at least 2:1.
5. The method according to claim 1 , comprising administering 25-hydroxyvitamin D 3 in an amount greater than 2 μg/kg/day.
6. The method according to claim 1 , comprising administering the 25-hydroxyvitamin D 3 and the 25-hydroxyvitamin D 2 within 6 hours of each other.
7. The method according to claim 6 , comprising first administering the 25-hydroxyvitamin D 3 and then administering the 25-hydroxyvitamin D 2 at a time when either the 25-hydroxyvitamin D 3 or a metabolic product thereof is detectable in serum.
8. The method according to claim 6 , comprising first administering the 25-hydroxyvitamin D 2 and then administering the 25-hydroxyvitamin D 3 at a time when either the 25-hydroxyvitamin D 2 or a metabolic product thereof is detectable in serum.
9. The method according to claim 1 , comprising administering said 25-hydroxyvitamin D 3 and 25-hydroxyvitamin D 2 to a patient diagnosed with vitamin D insufficiency and/or deficiency.
10. The method according to claim 1 , comprising administering said 25-hydroxyvitamin D 3 and 25-hydroxyvitamin D 2 in amount sufficient to raise and/or maintain the serum 25-hydroxyvitamin D level of the subject to at least 30 ng/mL.
11. The method according to claim 1 , wherein the subject is a human.
12. A method of vitamin D supplementation, comprising co-administering a vitamin D 3 supplement which is 25-hydroxyvitamin D 3 or 1,25-dihydroxyvitamin D 3 , and a vitamin D 2 supplement which is 25-hydroxyvitamin D 2 or 1,25-dihydroxyvitamin D 2 , and wherein the weight or molar ratio of 25-hydroxyvitamin D 3 or 1,25-dihydroxyvitamin D 3 to 25-hydroxyvitamin D 2 or 1,25-dihydroxyvitamin D 2 is at least 1.5:1 not 1:1.
13. The method according to claim 11 , wherein the subject has secondary hyperparathyroidism.
14. The method according to claim 1 , wherein the subject is a mammal.
15. The method according to claim 1 , wherein the administration of one or both of 25-hydroxyvitamin D 3 and 25-hydroxyvitamin D 2 is selected from oral, intravenous, topical, intraperitoneal and trans-dermal.
16. The method according to claim 15 , wherein the administration of 25-hydroxyvitamin D 3 is oral.
17. The method according to claim 16 , wherein the administration of 25-hydroxyvitamin D 2 is oral.
18. The method according to claim 15 , wherein the administration of 25-hydroxyvitamin D 3 is intravenous.
19. The method according to claim 18 , wherein the administration of 25-hydroxyvitamin D 2 is intravenous.