Semi-activated Vitamin D given weekly (used by Spanish COVID-19 trial) – US patent application
Once-a-Week Administration of 25-Hydroxy Vitamin D3 to Sustain Elevated Steady-State Pharmacokinetic Blood Concentration
United States Patent Application 20200281947 Kind Code:A1
Inventors: Deluca, Hector F. (Deerfield, WI, US). Plum, Lori A. (Arena, WI, US), Clagett-dame, Margaret (Deerfield, WI, US)
An oral dosage form comprising a single dose of 25-hydroxy-vitamin D3 sufficient to elevate the serum level in a human to a concentration in the range of 30 ng/ml to 200 ng/ml for at least 7 days and a pharmaceutically suitable oral carrier system, wherein subsequent single doses at least every 7 days are sufficient to sustain the serum level in a human to a concentration in the range of 30 ng/ml to 200 ng/ml at steady-state pharmacokinetics is disclosed. A method of elevating and sustaining the blood level concentration of 25-hydroxy-vitamin D3 in a human in need thereof comprising
orally administering or
parenterally administering by injection or infusion,
at least once every 7 days, a single dose of 25-hydroxy-vitamin D3 sufficient to elevate the serum level in a human to a concentration in the range of 30 ng/ml to 200 ng/ml for at least 7 days, wherein the single doses orally administered at least every 7 days are sufficient to sustain the serum level in a human to a concentration in the range of 30 ng/ml to 200 ng/ml at steady-state pharmacokinetics is disclosed. The human in need thereof may be a human deficient in vitamin D having a serum level concentration of 25-hydroxy-vitamin D3 less than 30 ng/ml.
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