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Table 4 Outcome of vitamin D supplement in CSU patients

From: Relationship between vitamin D and chronic spontaneous urticaria: a systematic review

Study, year Study design N Enroll Concomitant medications Intervention
(Dose, type, duration,source)
Duration Main outcome measurement Vitamin D status (ng/mL) Outcome
Before End of treatment
Sindher et al. [27] Case report 1 Chronic urticaria Calcium citrate 800 mg/day
Fexofenadine
Aluminium/magnesium antacid
Vitamin D3 (Cholecalciferol 400 IU/day 8 weeks ND 4.7 ND Continued to have intermittent urticaria
Then increased to 2000 IU/day) ND   ND 65 Complete resolution without antihistamine
Rorie et al. [26] Prospective,double-blinded, randomized controlled trial
(single-center clinical study)
42 CSU receiving high dose vitamin D3 (4000 IU/day) supplementation
(n = 21)
Cetirizine
Ranitidine
Montelukast
Use for intolerable or uncontrolled symptoms
Prednisolone
Hydroxychloroquine
Vitamin D3 4,000 IU/day 12 weeks USS Vitamin D status
(mean ± SE)
Decrease total USS scores
(mean ± SE)
28.8 ± 2.2 56.0 ± 3.9 15.0 ± 2.9
(p = 0.02)
CSU receiving low dose vitamin D3 (600 IU/day) supplementation
(n = 21)
  Vitamin D3 600 IU/day 37.1 ± 3.4 35.8 ± 2.3 24.1 ± 4.0
    Significant decrease in total USS score in the high, but not low, vitamin D3 treatment group by week 12 (p = 0.02)
No correlation between 25(OH)D levels and USS score at baseline (r = 0.07, p = 0.65) or at week 12 (r = 0.13, p = 0.45)
The high vitamin D3 treatment group showed a decreased total USS score compared with the low vitamin D3 treatment group, but this did not reach statistical significance (p = 0.052)
Subjects in the high vitamin D3 treatment group reported decrease body distribution of hives on an average day (p = 0.033), decrease body distribution of hives on the worst day (p = 0.0085), and decrease number of days with hives (p = 0.03) compared with subjects in the low vitamin D3 treatment group.
Study, year Study design N Enroll Concomitant
medications
Intervention (Dose, type, duration, source) Duration Main outcome measurement Vitamin D status
(ng/mL)
Outcome
Before End of treatment
Rasool et al. [25] Randomized case–control study 147 CSU
Any vitamin D levels (serum 25(OH)D) from
Group 1
Severe deficiency
Vitamin D levels < 10 ng/mL
Group 2
Deficient levels
Vitamin D levels
10–< 20 ng/mL
Group 3
Insufficient levels
Vitamin D levels
20–30 ng/mL
Group 4
Sufficient levels
Vitamin D levels
> 30 ng/mL)
Then randomized to
Sub-group A (n = 48)
sub-group B
(n = 42)
Sub-group C (n = 57)
  6 weeks VAS
5-D itch score
Vitamin D status
(mean ± SEM)
VAS score
(mean ± SEM)
5-D itch score
(mean)
Before After Before After Before After
Sub-group A Sub-group A Sub-group A Sub-group A
None Vitamin D3 (cholecalciferol) 60,000 IU/week for 4 weeks 16.98 ± 1.43 56.74 ± 3.76
(p < 0 .0001)
6.7 ± 0.043 5.2 ± 0.70
(p = 0.0088)
14.5 ± 0.72 12.06 ± 1.10
(p = 0.0072)
Sub-group B Sub-group B Sub-group B Sub-group B
Hydroxyzine
25 mg/day for 6 weeks
Corticosteroids
(deflazacort)
6 mg/day for 6 weeks
None 17.04 ± 1.54 16.44 ± 1.50 6.6 ± 0.42 3.3 ± 0.50
(p < 0.0001)
13.9 ± 0.77 8.1 ± 1.13
(p < 0.001)
Sub-group C Sub-group C Sub-group C Sub-group C
Hydroxyzine
25 mg/day for 6 weeks
Corticosteroids
6 mg/day for 6 weeks
Vitamin D3 60,000 IU/week for 4 weeks 18.95 ± 1.42 41.73 ± 2.85 (p < 0.0001) 6.68 ± 0.40 1.86 ± 0.39
(p < 0.0001)
13.9 ± 0.68 5.01 ± 0.94
(< 0.0001)
   Significantly decreased in VAS in every groups
Significantly decreased in 5D itch score in every groups
Improvement in the CSU symptoms in patients with vitamin D3 as monotherapy
Better improvement of symptoms and quality of life in combinatorial therapy group than standard therapeutic regimen group
Significant difference in VAS in subgroup A compared to subgroup B and C (p = 0.016 and p < 0.0001, respectively)
Significant difference in VAS in subgroup C compare to subgroup B (p = 0.0203)
Significant difference in 5-D score in subgroup A compared to subgroup B and C (p = 0.0116 and p < 0.0001, respectively)
Significant difference in 5-D score in subgroup C compared to subgroup B (p = 0.0382)
130 Healthy control None None 6 weeks Vitamin D levels Group 1 No change in serum 25(OH)D levels
7.310 ± 0.52 5.899 ± 0.28
Group 2
15.26 ± 0.47 16.96 ± 1.26
Group 3
23.98 ± 0.46 23.15 ± 0.95
Group 4
47.78 ± 2.23 49.18 ± 2.97
Oguz Topal et al. [24] Prospective case–control study 57
cases
CSU
Serum 25(OH)D < 30ug/L
None Vitamin D3 300,000 IU/month 12 weeks UAS4‡‡
CU-Q2oL
ND ND UAS4
(median(min–max))
CU-Q2oL
(median(min–max))
Before After Before After
21
(0–42.0)
6
(0–21.0)
(p < 0.001)
38
(6.5–115.2)
10.8
(0–43.4)
(p < 0.001)
Significant improvements in UAS4 and CU-Q2oL
Boonpiyathad et al. [31] Prospective case–control study 50
cases
CSU
Serum 25(OH)D < 30 ng/mL
(vitamin D supplement group)
Non-sedative antihistamine Ergocalciferol (vitamin D2) 20,000 IU/day 6 weeks UAS7
DLQI
13 (8–29) median (min–max) 40 (28–62) median (min–max) UAS7 DLQI scores
Before After Before After
27
(6–38)
15
(2–33)
13
(4–31)
6
(1–20)
10 controls CSU
Serum 25(OH)D ≥ 30 ng/ml
(non-vitamin D supplement group)
ND None 6 weeks UAS7
DLQI
37 (33–52)
median
(min–max)
38 (33–52)
median
(min–max)
26
(18–42)
26
(16–44)
12
(5–28)
14
(3–27)
Significant improvements in UAS7 and DLQI scores in the vitamin D supplement group compared with the non-vitamin D supplement group
Significant improvement of the median UAS7 score in the vitamin D supplement group than in the non-vitamin D supplement group
Significantly improvement of the median DLQI score in the vitamin D supplement compared with the non-vitamin D supplement group
None of the patients in the vitamin D supplement group were symptom-free at the optimal vitamin D levels.
Ariaee et al. [19] Prospective study 20 CSU
Serum vitamin D concentration < 10 ng/mL
ND Vitamin D 50,000 unit/week 8 weeks USS
DLQI
ND ND USS (mean ± SD) DLQI scores (mean ± SD)
Before After Before After
235 ± 13.9 11.2 ± 9.6 10.8 ± 1.6 0.9 ± 4.8
Significant reduction in USS after vitamin D supplement
Improvement of DLQI (55%) after vitamin D supplement
Increase FOXP3 gene expression and downregulation of IL-10, TGF-beta and FOXP3, IL-17 after vitamin D supplement
Dabas et al. [32] Randomized controlled trial 200 CSU
Serum 25(OH)D < 30 nmol/L
Levocetirizine 10 mg/day Group A
Vitamin D 2000 IU/day
Group B
Vitamin D 60,000 IU/week
Group C
None
12 weeks UAS4 ND ND UAS4 (mean)
Before After 6 weeks After 12 weeks
Group A
11.8 ± 7.6 6.6 ± 6.0 5.3 ± 5.2
Group B
13.0 ± 8.0 6.4 ± 5.0 4.2 ± 3.5
Group C
12.9 ± 7.03 8.0 ± 5.7 6.1 ± 4.8
No significant difference in mean UAS4 in the 3 groups after 12 weeks of vitamin D replacement
Vitamin D replacement decreased the severity in most patients.
  1. 25(OH)D, 25-hydoxyvitamin D; 5-D itch score, 5-dimension itch score; CSU, chronic spontaneous urticaria; CU-Q2oL, Chronic Urticaria Quality of Life Questionnaire; DLQI, Dermatology Life Quality Index; IL, interleukin; TGF, transforming growth factor; ND, not defined; UAS, urticaria activity score; USS score, the Urticaria Symptom Severity Score; VAS, visual analogue scale
  2. ‡‡UAS4 (the Urticaria Activity Score over 4 days; (scale 0–6) calculated as the sum of daily average morning and evening scores for itch severity (0, none; 1, mild; 2, moderate; 3, severe) and number of hives (0, none; 1, < 20 hives; 2, 20–50 hives; and 3, > 50 hives)