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Table 2 Efficacy outcomes

From: Impact of two oral doses of 100,000 IU of vitamin D3 in preschoolers with viral-induced asthma: a pilot randomised controlled trial

 

Vitamin D

Placebo

Adjusted incidence rate ratio

Adjusted relative risk

Adjusted mean difference

events

(number)

Mean (95% CI)

N = 23

events

(number)

Mean (95% CI)

N = 24

(95% CI)

(95% CI)

(95% CI)

URTI episodesa

 Incidence of URTIs/childb

  Verbal report - mean group rate/child

98

4.48 (3.66, 5.49)

95

4.12 (3.37, 5.03)

1.24 (0.88, 1.75)

  

  Diary - mean group rate/childc

44

3.63 (2.70, 4.87)

64

4.24 (3.32, 5.42)

0.92 (0.58, 1.49)

  

Asthma exacerbations with URTIsa

 Incidence of exacerbations/childb

  Verbal report - mean group rate/child

61

2.84 (2.20, 3.67)

44

1.91 (1.42, 2.56)

1.78 (1.10, 2.90)

  

  Diary - mean group rate/childc

33

2.72 (1.93, 3.83)

52

3.71 (2.83, 4.87)

0.74 (0.43, 1.27)

  

 Intensity of asthma symptoms/episoded

  Diary - cumulative daily ADYC scorese, c

34

11.0 (8.9, 13.2)

54

12.5 (9.8, 15.1)

  

−0.7 (−3.7, 2.2)

 Duration of exacerbations in daysd

  Verbal report - mean group duration/episode

57

7.6 (5.1, 10.0)

43

7.4 (5.8, 9.0)

  

1.0 (−3.0, 4.9)

  Diary - mean group duration/episoded, c

34

5.1 (3.1, 7.0)

54

5.2 (4.2, 6.2)

  

0.3 (−1.9, 2.6)

 Intensity of β2-agonist use per episodef

  Diary - cumulative number of puffsc

33

40.1 (30.4, 49.8)

51

41.2 (32.1, 50.2)

  

−1.4 (− 13.5, 10.7)

 Impact on parents during URTIa

  Parental functional statusg

35

3.3 (2.8, 3.9)

49

3.2 (2.6, 3.8)

  

−0.1 (−1.3, 1.0)

  Workday-missed/episode

36

1.0 (0.3, 1.7)

50

1.7 (0.9, 2.5)

  

0.1 (−1.2, 1.3)

Healthcare service utilisation

 Courses of oral steroids/child

22

0.96 (0.63, 1.45)

19

0.79 (0.51, 1.24)

1.21 (0.57, 2.57)

  

 Acute care visits for asthma/child

24

1.04 (0.70, 1.56)

24

1.00 (0.67, 1.49)

1.34 (0.69, 2.63)

  
  

Proportion (95% CI)

 

Proportion (95% CI)

   

 Subjects with ≥ 1 course of oral steroids

14

61 (40, 78) %

10

42 (24, 62) %

 

1.36 (0.42, 4.47)

 

 Subjects with ≥ 1 acute care visit

15

65 (44, 82) %

12

50 (31, 69) %

 

1.63 (0.51, 5.21)

 
  1. Values for each group are reported as mean (95% CI). Unless otherwise specified, all summary estimates (odds ratio, rate ratio, and mean difference) were analyzed by intention-to-treat with adjustment for the clustering of upper respiratory tract infections (URTIs) by individuals and offset to account for varying person-time, when applicable
  2. ADYC Asthma flare-up diary for young children [30]
  3. aAn upper respiratory tract infection (URTI) was deemed to have occurred when reported by parents at monthly contacts or in diaries. The number of URTIs for which a complete set of diaries was available is indicated for each outcome
  4. bStandardised over 210 days (i.e., 7 months, the expected duration of the study) to account for varying person-time
  5. cChildren who did not complete any asthma diaries were excluded from the calculation of the summary estimates
  6. dDuration from the first day with two or more asthma symptoms to the last day with one or more asthma symptoms (cough, wheezing, and/or dyspnea) as reported by parents on the monthly contact and/or diary. Up to one day without asthma symptoms could be included in an exacerbation. URTIs with incomplete reports and diaries were discarded
  7. eMeasured on the 17-item ADYC [30], on a scale of 1 (best) to 7 (worst), completed daily from the beginning until the end of asthma symptoms during exacerbation. The cumulative symptoms intensity represents the sum of the daily ADYC scores per episode (URTI or exacerbation). The ADYC items pertained to the cough (N = 2), wheezing (N = 2), dyspnea (N = 4), night awakenings (N = 1), general wellbeing (N = 5), and child’s response to albuterol inhalations (N = 3)
  8. fCumulative number of inhalations during asthma exacerbations, standardized over 7 days, as recorded on the ADYCs. Albuterol doses received during acute care visits and hospital admissions were not considered. URTIs with missing or incomplete ADYCs were discarded
  9. gAverage score on 'Effects of a Young Child’s Asthma Flare-up on the Parents, (ECAP) Questionnaire (best = 7, worst =1)