Yadav 2014.
Methods | Randomised, double‐blind, placebo‐controlled, parallel‐group trial Single‐centre, 6 months long Run‐in period: Not described, concomitant medication continued 18 were lost to follow‐up, reasons not provided Study analysed by intention‐to‐treat |
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Participants | Rohtak, India Indian N = 100. 49 m, 51 f. Mean age 9.6 yrs, range 5 to 13 yrs Inclusion criteria:
Exclusion criteria:
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Interventions | Treatment (n = 50): oral vitamin D3 (cholecalciferol) 60,000 IU per month for 6 months. Control (n = 50): placebo powder in the form of glucose sachet. Vitamin D status not assessed |
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Outcomes |
Primary outcome: Change in the level of asthma severity according to GINA guidelines. Secondary outcomes:
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Notes | No details on funding provided. Authors declare no conflict of interest |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of sequence generation not reported |
Allocation concealment (selection bias) | Low risk | Allocation concealed in opaque envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, placebo‐controlled trial |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blind, placebo‐controlled trial |
Incomplete outcome data (attrition bias) All outcomes | High risk | 10/50 children in control arm and 8/50 in active arm were lost to follow‐up, but data for these 'lost' children are presented at the 6‐month time point (end of study) |
Selective reporting (reporting bias) | Low risk | Nil to suggest selective reporting: outcomes listed in Methods are reported in Results. However, we did not have access to the trial protocol |
Other bias | High risk | Marked change in classification of asthma severity between 6‐month time point and earlier time points suggests likelihood of misclassification bias operating at end‐study time point |
25(OH)D, 25‐hydroxyvitamin D; ACT, Asthma Control Test; ASUI, Asthma Symptom Utility Index; ATAQ, Asthma Therapy Assessment Questionnaire; COPD, chronic obstructive pulmonary disease; FeNO, fractional exhaled nitric oxide concentration; FEV1, forced expiratory volume in one second; GFR, glomerular filtration rate; ICS, inhaled corticosteroids; IgE, immunoglobulin E; ITT, intention to treat; IU, international unit (40 IU vitamin D = 1 microgram vitamin D); PC20, provocative concentration of methacholine at which FEV1 decreased by 20%; PEFR, peak expiratory flow rate; SCRG, St George's Respiratory Questionnaire; SIT, specific immunotherapy; URTI, upper respiratory tract infection.