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) |
COVID Immune: Baseline | COVID Immune: 12 mth follow-up |
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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) |
1-5 years | 2-6 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 |
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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 |
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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
SDV: Study Devised Variable
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) |