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Epidemiological and observational studies have linked vitamin D deficiency with increased asthma/allergy incidence . Vitamin D insufficiency (<75nmol/L) has been associated with increased incidence of severe childhood asthma. Further, high 25(OH)D levels were associated with reduced risk of recent hospitalization, lower use of anti-asthmatic medication and lower airway hyper-responsiveness in childhood asthmatics. The association between vitamin D and allergy and asthma appears to be stronger in children than adults, with some even suggesting that childhood asthma may may be caused by VDD.
Asthmatic children will be recruited in winter. After baseline testing, children will be randomized to take 2,000iu vitamin D or placebo daily for 15 weeks. After the 15 weeks, testing will be repeated. Tests involve blood draws, questionnaires and breathing tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 2,000iu vitamin D3 per day for 15 weeks |
|
| Placebo | Placebo Comparator | An identical placebo capsule daily for 15 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Soft gel capsules will be identical to the vitamin D intervention but contain no vitamin D. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Paediatic Asthma Control Test (P-ACT) | 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Global Initiative for Asthma Score | 15 weeks | |
| Pulmonary function | FEV1, FVC, FEV1:FVC | 15 weeks |
| Height velocity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Basil Elnazir, MD | National Children's Hospital, Dublin 24, Ireland | Principal Investigator |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| VItamin D3 | Dietary Supplement | Soft gel capsules will contain 2,000IU vitamin D. |
|
Rate of change in height |
| 15 weeks |
| Biochemical markers (25(OH)D, total IgE, total calcium, albumin, PTH, phosphate, hsCRP, IgA and ECP. | 15 weeks |
| Mini paediatric asthma quality of life questionnaire | 15 weeks |
| Asthma Diary | A 13 item diary to be filled out weekly by parents/gaurdians. | 15 weeks |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |