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The role of vitamin D in respiratory health remains uncertain. Whether vitamin D reduces clinically important exacerbations of childhood asthma remains uncertain. We compared rapid to maintenance vitamin D repletion analyzed by baseline vitamin D level.
Recently published Cochrane metaanalysis suggested that vitamin D reduces the risk of severe asthma exacerbations, but only 22 children contributed to that analysis from a study that found no difference in acute care visits or rescue steroid administration. Altogether, randomized trials performed in children show promise solely in meta-analyses that use varied clinical outcomes and analysis approaches.
Were vitamin D supplementation beneficial for children with asthma, it might prevent moderate to severe asthma exacerbations entirely in some children, reduce the overall frequency of exacerbations in a treated group, or both. To examine these possibilities, we designed a randomized explanatory study comparing rapid vs maintenance vitamin D supplementation for children with moderate-to-severe asthma and with low baseline vitamin D levels .
Children presenting to the ED with moderate-to-severe asthma exacerbations and vitamin D levels < 25 ng/mL underwent masked randomization, and then open dosing to either IM+oral (the latter daily) therapy or daily oral-only therapy, and were followed for 12 months.The primary outcome was patient-initiated unplanned visits for asthma exacerbations,examined two ways: cumulative proportions with an exacerbation, and average exacerbation frequency. As this was a nutrient study, we analyzed treatment groups by quartile of baseline vitamin D level, collecting repeat levels and clinical observations at 3, 6, 9,and 12 months after enrollment.
One hundred and sixteen patients in the IM+oral cohort vs 115 in the oral-only cohort had similar mean (SD) baseline levels: 15.1 (5.4) vs 15.8 (5.2) ng/mL (range, 3-25 ng/mL). There was no difference in the primary outcome over the entire 12-month observation period. However, rapid IM+oral supplementation significantly reduced unplanned visits for asthma exacerbations for children with baseline levels of 3 to 11 ng/mL during the initial 3 months: the relative exacerbation rate for the IM+oral cohort compared with the oral-only cohort at 3 months was 0.48 (95% CI, 0.28-0.89; P ¼ .008); average exacerbation frequency per child analysis, relative rate 0.36 (95% CI, 0.13-0.87; P ¼ .017).
So Rapid compared to maintenance vitamin D supplementation for children with the lowest levels resulted in short- but not long-term reduction in asthma exacerbations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injectable + oral vitamin D | Active Comparator | Children with moderate-to-severe asthma exacerbations and vitamin D levels < 25 ng/mL. |
|
| Oral-only Vitamin D | Active Comparator | Children with moderate-to-severe asthma exacerbations and vitamin D levels < 25 ng/mL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | Children with moderate-to-severe asthma exacerbations and vitamin D levels < 25 ng/mL underwent masked randomization, and then open dosing to either IM+oral (the latter daily) therapy or daily oral-only therapy, and were followed for 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute asthma exacerbations avoidable events . | Rapid compared to maintenance oral supplementation with vitamin D significantly reduced unplanned visits for asthma exacerbations for children with baseline levels of 3 to 11 ng/mL during the initial 3 months of treatment but not thereafter. | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Daily symptom burden differ in slow versus rapid vitamin D deficiency correction in patients with moderate to severe asthma | Rapid compared to maintenance vitamin D supplementation for children with the lowest levels resulted in short- but not long-term reduction in asthma exacerbations. | 12 month |
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Inclusion Criteria:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Dr.Khalid Al-Ansari | Hamad Medical Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamad Medical Corporation, Pediatric Emergency Center,Alsaad. | Doha | 3050 | Qatar |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D014808 | Vitamin D Deficiency |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |