Is the combination of pharmacotherapy and nonpharmacotherapy more effective than nonpharmacotherapy alone at improving sleep-onset insomnia?

Abstract

NNT515). Vitamin D dosing did not provide protection against ARI-associated hospitalizations, emergency room visits, or use of antimicrobials or high-dose steroids. No increase in adverse events was noted with vitamin D supplementation. Limitations included diverse definitions of ARI among studies and limited data on patient adherence to treatment.A 2020 double-blind RCT (n55,110) examined the effectiveness of monthly high-dose vitamin D supplementation for prevention of ARI compared with placebo in older adults. 2 Patients were adults 50 to 84 years old (mean 66.4 years old) recruited from family medicine registers and community groups in Auckland, New Zealand. Patients were 42% female and 83% were of European ethnicity. Patients were excluded if they had a history of disease that could cause hypercalcemia, a history of renal stones, a baseline serum calcium .10 g/dL, a terminal illness, or were in hospice care. The intervention group received vitamin D3 100,000 IU soft-gel oral capsules with a one-time loading dose of 200,000 IU, followed by a monthly dose of 100,000 IU for two years, whereas the control group received identical placebo capsules. The primary outcome was time to first reported ARI; secondary outcomes were components of ARI measured at monthly follow-ups assessing recent respiratory infections. Over the 1.6 years of the trial, 1,882 patients (74.1%) in the vitamin D3 cohort reported at least one ARI, compared with 1,855 (73.7%) in the placebo cohort (adjusted hazard ratio 1.01; 95% CI, 0.97-1.07), indicating no significant difference. The study was limited by using no objective measures for confirming ARIs.