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Table 1 Schedule of procedures, assessments, and interventions for the DO IT! Trial (based on the SPIRIT template)

From: DO IT Trial: vitamin D Outcomes and Interventions in Toddlers a TARGet Kids! randomized controlled trial

 

Study period

Pre-randomization

Intervention

Post-intervention follow-up

Close-out

TIMEPOINT

Year 1

0

Year 1

Year 1

 

Sept – Nov

 

Sept – March

April – May

Year 2

 

Year 2

Year 2

Sept – Nov

 

Sept – March

April – May

Year 3 and 4

 

Year 3 and 4

Year 3 and 4

Year 4

Sept – Nov

 

Sept – March

April – May

June – Aug

INTERVENTIONS:

     

‘Standard dose’ 400 IU/day

 

X

X

  

‘High dose’ 2000 IU/day

 

X

X

  

PROCEDURES:

     

Informed consent

X

    

Eligibility screen

X

    

Randomization

 

X

   

ASSESSMENTS:

     

Baseline survey data

X

X

   

Anthropometrics

 

X

   

25-hydroxyvitamin D serum level

  

X

X

 

Laboratory-confirmed URTI

  

X

  

Asthma exacerbations

  

X

  

Follow-up survey data

   

X

 

ANALYSIS

    

X