High-Dose Monthly Vitamin D for Prevention of Acute Respiratory Infection in Older Long-Term Care Residents: A Randomized Clinical Trial
Journal of the American Geriatrics Society, First published: 16 November 2016, DOI: 10.1111/jgs.14679
Adit A. Ginde MD, MPH, Patrick Blatchford PhD, Keith Breese MA, Lida Zarrabi MPH,
Sunny A. Linnebur PharmD, Jeffrey I. Wallace MD, MPH, Robert S. Schwartz MD
RCT with 100,000 IU monthly to 107 seniors in long term care facility Trial lasted for 12 months Decreased acute respiratory infection by 40% Increased risk of falls by 2.3 X No difference in nunber of fractures between the groups
VitaminDWiki suspects Those getting high dose vitamin D felt better ==> moved more ==>fell more
A RCT does not permit warning high dose participants to beware of moving more when feeling better
Note th high dose group only achieved a median of 32 ng/mL That is, half had more than 32 ng and half had less than 32 ng Need much more Vitamin D (200,000 montly?) to get most of participants above 32 ng
Objectives: To determine the efficacy and safety of high-dose vitamin D supplementation for prevention of acute respiratory infection (ARI) in older long-term care residents.
Design: Randomized controlled trial investigating high-dose vs standard-dose vitamin D from 2010 to 2014.
Setting: Colorado long-term care facilities.
Participants: Long-term care residents aged 60 and older (n = 107).
Intervention: The high-dose group received monthly supplement of vitamin D3 100,000 IU, the standard-dose group received a monthly placebo (for participants taking 400–1,000 IU/d as part of usual care) or a monthly supplement of 12,000 IU of vitamin D3 (for participants taking <400 IU/d as part of usual care).
Measurements: The primary outcome was incidence of ARI during the 12-month intervention.
Secondary outcomes were falls and fractures, 25-hydroxyvitamin D levels, hypercalcemia, and kidney stones.
Results: Participants (55 high dose, 52 standard dose) were randomized and included in the final analysis.
The high-dose group had 0.67 ARIs per person-year and the standard-dose group had 1.11 (incidence rate ratio (IRR) = 0.60, 95% confidence interval (CI) = 0.38–0.94, P = .02).
Falls were more common in the high-dose group (1.47 per person-year vs 0.63 in standard-dose group; IRR = 2.33, 95% CI = 1.49–3.63, P < .001).
Fractures were uncommon and similar in both groups (high dose 0.10 vs standard dose 0.19 per person-year; P = .31).
Mean trough 25-hydroxyvitamin D levels during the trial were 32. ng/mL in the high-dose group and 25.1 ng/mL in the standard-dose group.
There was no hypercalcemia or kidney stones in either group.
Conclusion: Monthly high-dose vitamin D3 supplementation reduced the incidence of ARI in older long-term care residents but was associated with a higher rate of falls without an increase in fractures.
Table from study
|
System Organ Class |
High Dose |
Standard Dose |
|
|
n (%) |
|
|
Blood and lymphatic system disorders |
7 (13) |
4 (8) |
|
Cardiac disorders |
15 (27) |
9 (17) |
|
Dermal and epidermal conditions |
0 (0) |
0 (0) |
|
Ear and labyrinth disorders (cause falls?) |
6 (11) |
1 (2) |
|
Endocrine disorders |
3 (5) |
0 (0) |
|
Eye disorders (fewer) |
5 (9) |
7 (13) |
|
Gastrointestinal disorders (fewer) |
22 (40) |
27 (52) |
|
General disorders and administration site conditions |
39 (71) |
28 (54) |
|
Hepatobiliary disorders |
1 (2) |
1 (2) |
|
Immune system disorders |
9 (16) |
7 (13) |
|
Infections and infestations |
21 (38) |
21 (40) |
|
Injury, poisoning, and procedural complications |
29 (53) |
30 (58) |
|
Investigations |
16 (29) |
12 (23) |
|
Metabolic, nutritional, and blood gas investigations |
18 (33) |
15 (29) |
|
Musculoskeletal and connective tissue disorders |
17 (31) |
16 (31) |
|
Neoplasms benign, malignant, and unspecified |
1 (2) |
1 (2) |
|
Nervous system disorders |
10 (18) |
10 (19) |
|
Neuromuscular disorders |
1 (2) |
0 (0) |
|
Ocular infections, irritations, and inflammations |
0 (0) |
0 (0) |
|
Psychiatric disorders |
30 (55) |
19 (37) |
|
Renal and urinary disorders |
13 (24) |
10 (19) |
|
Reproductive systems and breast disorders |
6 (11) |
2 (4) |
|
Respiratory, thoracic, and mediastinal disorders |
24 (44) |
30 (58) |
|
Skin and subcutaneous tissue disorders |
23 (42) |
22 (42) |
|
Social circumstances |
1 (2) |
0 (0) |
|
Surgical and medical procedures |
14 (25) |
6 (12) |
|
Vascular disorders |
0 (0) |
0 (0) |
|
Total with ≥1 adverse events |
53 (96) |
49 (94) |