Efficacy and Safety of Intramuscular Injections of Vitamin D3 B.O.N. on Serum Vitamin D Levels in Adults with Vitamin D Deficiency: A Prospective, Single-Center, Open-Label Study
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Background: Vitamin D deficiency is a common challenge its consequences are studied to be related to diversity of other health concerns. The efficacy and safety in longevity of vitamin D3 B.O.N. 200,000 IU Intramuscular Injection were examined through investigator-initiated clinical trial.Methods: One-hundred and eight subjects between ages of 19 and 65 who showed vitamin D deficiency (serum 25(OH)D<20 ng/mL) were initially injected once and were checked every 3 months for the next 12 months for serum 25(OH)D and 1,25(OH)2D levels for the drug’s efficacy, and for other safety observations. The percentage of participants maintaining within the normal serum 25(OH)D range were analyzed. Participants who reduced in the serum level below 30 ng/mL during the regular visits were given additional injections.Results: All the subjects showed similar patterns of statistically significant improvements at all times. The percentage of participants remaining in the normal range was higher in the better compliance group. No serious adverse events or severe adverse reactions occurred.Conclusions: Treatment of the vitamin D-deficient subjects with the injection of 200,000 IU vitamin D3 B.O.N. Intramuscular Injection induced a statistically significant increase in blood vitamin D concentration for 12 months demonstrating the clinical efficacy of the intervention. The higher percentage of the better compliance group being within normal ranges strengthens the evidence of the efficacy. No new adverse events or severe adverse events were associated with the injection, demonstrating its safety. Further studies to facilitate development of appropriate guidelines for interventions using vitamin D3 intramuscular injections will be desirable.
Abstract
Background: Vitamin D deficiency is a common challenge its consequences are studied to be related to diversity of other health concerns. The efficacy and safety in longevity of vitamin D3 B.O.N. 200,000 IU Intramuscular Injection were examined through investigator-initiated clinical trial.Methods: One-hundred and eight subjects between ages of 19 and 65 who showed vitamin D deficiency (serum 25(OH)D<20 ng/mL) were initially injected once and were checked every 3 months for the next 12 months for serum 25(OH)D and 1,25(OH)2D levels for the drug’s efficacy, and for other safety observations. The percentage of participants maintaining within the normal serum 25(OH)D range were analyzed. Participants who reduced in the serum level below 30 ng/mL during the regular visits were given additional injections.Results: All the subjects showed similar patterns of statistically significant improvements at all times. The percentage of participants remaining in the normal range was higher in the better compliance group. No serious adverse events or severe adverse reactions occurred.Conclusions: Treatment of the vitamin D-deficient subjects with the injection of 200,000 IU vitamin D3 B.O.N. Intramuscular Injection induced a statistically significant increase in blood vitamin D concentration for 12 months demonstrating the clinical efficacy of the intervention. The higher percentage of the better compliance group being within normal ranges strengthens the evidence of the efficacy. No new adverse events or severe adverse events were associated with the injection, demonstrating its safety. Further studies to facilitate development of appropriate guidelines for interventions using vitamin D3 intramuscular injections will be desirable.
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