VITALITY: Trial specific information
| Wave | Baseline | Compliance monitoring (2-3 months after enrolment) |
Follow-up 6 months old |
Clinic visit (optional) (6 months) |
Follow-up 9 months old |
Follow-up 12 months old |
Clinical assessment (12 months) |
|---|---|---|---|---|---|---|---|
| Age | 7.2 weeks (6.0 – 12.1 weeks) |
3 months | 6 months | 6 months | 9 months | 12 months | 1.14 years (1.01 – 1.4 years) |
| Randomisation | X | ||||||
| Vitamin D/placebo dispensed | X | X | |||||
| VitaminD/placebo returned and counted | X | X | |||||
| Daily medication compliance diary | P:SDV | P:SDV | P:SDV | P:SDV | P:SDV | P:SDV | |
| Infant feeding method (breastfeeding/formula status and history, formula type used) |
P:SDV | P:SDV | P:SDV | P:SDV | |||
| History of disease, illness and infection (including health services utilisation) |
P:SDV | P:SDV | P:SDV | P:SDV | |||
| Number of lower respiratory infections (including accessing GP or hospital records) |
P:SDV | P:SDV | P:SDV | P:SDV | |||
| Skin condition (including eczema, dry, itchy, cracked, flaky or weeping/oozing skin) |
P:SDV | P:SDV | P:SDV O:SCORAD |
P:SDV | P:SDV | P:SDV O:SCORAD |
|
| Medications (topical steroids for skin conditions, antacids or anti-reflux, paracetamol, ibuprofen, aspirin) |
P:SDV | P:SDV | |||||
| History of medication/supplement use (including topical steroids for skin conditions, antacids or anti-reflux, paracetamol, ibuprofen, aspirin, vitamin D, iron, antibiotics) |
P:SDV | P:SDV | P:SDV | P:SDV | |||
| Vitamin D deficiency (serum vitamin D < 50 nmol/L) |
X | X | |||||
| Vitamin D metabolism markers (vitamin D binding protein, calcium phosphatase, alkaline phosphatase, parathyroid hormone) |
X | ||||||
| Immunological measurements (food-related IgE) |
X | ||||||
| Chest examination | O | O | |||||
| Health review before clinical assessment | P:SDV O:SDV |
||||||
| Skin prick test | O:SPT | ||||||
| Oral food challenge | O:OFC (if positive SPT) |
Featured measurements
OFC: Oral Food Challenge (HealthNuts protocol)SCORAD: SCORing Atopic Dermatitis
SPT: Skin Prick Test (HealthNuts protocol)
Legend
| A | = Administration report abstraction |
| C | = Index child report (reporting on others) |
| L | = Linkage (to other databases) |
| M | = Medical records data abstraction |
| O | = Observation/direct assessment |
| N | = Nurse report |
| P | = Parent/primary caregiver report |
| Pe | = Peer report |
| S | = Self report |
| T | = Teacher report |
| X | = Undefined |
| X BF | = Pertaining to biological father |
| X BM | = Pertaining to biological mother |
| X C | = Pertaining to index child |
| X F | = Pertaining to father |
| X Fam | = Pertaining to family |
| X G | = Pertaining to grandparent(s) |
| X M | = Pertaining to mother |
| X P | = Pertaining to parent(s) |
| X Pa | = Pertaining to partner |
| X Pe | = Pertaining to peers |
| X Pr | = Pertaining to primary caregiver |
| X Si | = Pertaining to sibling(s) |