Table 1.
Clinic visits | Randomisation | 7±3 d | 10±3 d | 1 m | 2 m | 3.5±0.5 m | 7±3 d* | 10±3 d* | 5 m | 6 m | 7±0.5 m |
Blood and urine samples | ✓ | ✓ | ✓ | ||||||||
Asthma phenotype and treatment | ✓ | ✓ | ✓ | ||||||||
Sun exposure questionnaire, anthropometry | ✓ | ✓ | ✓ | ||||||||
Skin colour (Fitzpatrick scale) | ✓ | ||||||||||
Atopy (serum IgE) | ✓ | ||||||||||
Dietary intake (vitamin D, Calcium) | ✓ | ✓ | ✓ | ||||||||
Weighting of daily vitamin D bottles | ✓ | ✓ | ✓ | ||||||||
Dispensing and/or exchange of parent questionnaires | ✓ | ✓ | ✓ | ||||||||
Nasal swab | ✓ | ✓ | |||||||||
Adverse health events | ✓ | ✓ | ✓ | ||||||||
URTIs, exacerbations, medications, acute care visits or hospitalisations | ✓ | ✓ | ✓ | ||||||||
Daily vitamin D supplement compliance | ✓ | ✓ | |||||||||
Home visits | |||||||||||
Urine samples | ✓ | ✓ | |||||||||
Blood samples† | (✓) | ||||||||||
Telephone contacts | |||||||||||
Adverse health events | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
URTIs, exacerbations, medications, emergency visits or hospitalisations, parental work absenteeism and expenses | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
Daily vitamin D supplement compliance | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||
During each asthma flare-up or URTI | |||||||||||
Asthma flare-up diary for young children71 | |||||||||||
Effect of a child’s asthma flare-up on parents72 | |||||||||||
Summary of cold or asthma flare-up form | |||||||||||
Nasal swab (parent-collected) | |||||||||||
Laboratory analyses | |||||||||||
Urinary calcium:creatinine ratio | ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
Serum calcium, phosphorus and ALP | ✓ | (✓) | (✓) | (✓) | (✓) | ||||||
Serum 25-hydroxyvitamin D | (✓) | (✓) | (✓) | (✓) | (✓) |
(✓)refers to a specimen sampled but not routinely analysed unless specifically requested by the Site endocrinologist.
*The delay is counted since the second bolus at 3.5±0.5 months.
†In a subset of patients recruited in two institutions.
ALP, alkaline phosphatase; d, days; m, months; URTI, upper respiratory tract infection.