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
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
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
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)